Q&A Collection 1 — Full Text (38 questions)

Q（Question）

May information provision activities conducted under GCP, GPSP, or GVP be considered outside the scope of these Guidelines?

A（MHLW answer）

The Guidelines target 'sales information provision activities,' and information provision activities conducted under these laws may be considered outside the scope.

Please note that such information provision activities must be conducted in full compliance with the respective relevant laws and regulations.

So what (meaning): Statutory information provision under GCP (clinical trials), GPSP (post-marketing surveillance), and GVP (safety management) falls outside the MSA Guidelines. Compliance with each underlying law still applies.

So why (rationale): The Guidelines regulate activities conducted with an expectation of promoting sales; legally mandated information provision is inherently different in character and therefore excluded from scope.

Commentary — background, application, practical notes

GCP, GPSP, and GVP are all legally mandated procedures imposed on marketing authorization holders under the pharmaceutical regulatory framework. Typical activities include transmitting safety information from clinical trials, conducting and reporting post-marketing surveillance studies, and collecting and reporting adverse reaction data to regulatory authorities. Because these activities are performed as statutory obligations rather than with any expectation of promoting sales, they fall outside the definition of 'sales information provision activities' that the Guidelines regulate.

In practice, typical scenarios include providing adverse reaction information to healthcare institutions as part of periodic safety reporting under GVP, or explaining specific post-marketing studies to attending physicians as required under GPSP. The Guidelines do not apply in such cases, but compliance with the underlying GVP and GPSP ordinances themselves continues to be required.

The boundary that is most easily misjudged is the case where the form of legally based information provision is maintained while the substance promotes the efficacy or superiority of the company's own product. For example, if a company uses an occasion for GVP safety communication to simultaneously introduce favorable trial results for its own product, that additional information provision may still fall within the Guidelines. The existence of a legal basis does not itself prove that an activity lacks a promotional character.

Q（Question）

May 'expecting sales promotion' in the definition of 'sales information provision activities' be considered synonymous with 'customer inducement' (i.e., a clear intent to enhance customers' desire to purchase), one of the three criteria for advertisement applicability?

A（MHLW answer）

The Guidelines were established to address and improve the current situation, covering not only clear false or exaggerated advertising but also activities that are difficult to classify as advertisements yet may encourage inappropriate or incorrect use of medicines — including advertisement-like activities.

Therefore, as the Guidelines also target advertisement-like activities, 'expecting sales promotion' encompasses customer inducement, and the two are not necessarily synonymous.

So what (meaning): 'Expecting sales promotion' is a broader concept than customer inducement; advertisement-like activities that do not meet the three advertisement criteria are still covered by the Guidelines.

So why (rationale): The Guidelines were designed to address 'gray zone' activities not fully captured by the Pharmaceuticals and Medical Devices Act, where selective or misleading information provision was encouraging inappropriate drug use.

Commentary — background, application, practical notes

The advertising regulations under the Pharmaceuticals and Medical Devices Act apply when three criteria are all satisfied: (1) customer inducement — a clear intent to stimulate the desire to purchase; (2) specificity — a particular product or product name can be identified; and (3) noticeability — the communication reaches the general public in a recognizable form. The defining characteristic of the Guidelines is that they extend to 'advertisement-like activities' that fall short of all three criteria — that is, the gray zone of activities where one or two criteria are absent and the pharmaceutical advertising rules do not directly apply.

A typical scenario is a 'disease education' seminar funded by a pharmaceutical company whose content primarily emphasizes the clinical positioning of the company's own product. Even when such an event does not meet all three advertising criteria because it stops short of explicitly naming the product, it still falls within the Guidelines if the activity is conducted with an expectation of generating sales.

The most common practical mistake is the binary thinking that 'if it is not an advertisement, it is not regulated.' The phrase 'with an expectation of promoting sales' has been clarified as a broader concept than customer inducement, capturing activities that do not explicitly aim to stimulate a purchase desire. Whether the materials or information provided will produce a promotional effect in substance is what matters; confirming that something is not an 'advertisement' under the Act does not by itself ensure compliance with the Guidelines.

Q（Question）

Regarding the definition of 'sales information provision activities,' may the transmission of information related to preparation for marketing approval applications or label expansions by a clinical development division within a marketing authorization holder be considered outside the scope of the Guidelines?

A（MHLW answer）

Whether an activity constitutes a 'sales information provision activity' is assessed and determined individually based on the actual activities conducted; therefore, a purely formal judgment based on organizational unit or stated purpose alone does not automatically exclude the activity from the scope of the Guidelines.

So what (meaning): Being classified as a clinical development team or citing 'approval preparation' as the purpose does not automatically exempt an activity. The actual content of each activity must be individually assessed.

So why (rationale): Allowing exemptions based on organizational labels or stated purposes would create loopholes; the principle of assessing actual activity content was adopted to prevent circumvention.

Commentary — background, application, practical notes

The concern underlying this Q&A is how to respond to attempts to use an organizational unit's name or its formally stated purpose to escape the reach of the Guidelines. While clinical development divisions exist to secure product approvals, activities conducted during the pre-approval preparation phase may still qualify as sales information provision activities if they generate interest in a specific product among the intended audience.

A concrete example is a clinical development employee briefing physicians on interim trial results or the status of a development program before the approval application is filed. Even when this is characterized as collecting expert opinion to support the application, the practical effect on a physician who listens with future prescribing in mind can make the activity promotional in substance.

The boundary that is easily misjudged is the reasoning that 'since the product is not yet approved, this cannot yet be a promotional activity.' Even at the pre-approval stage, an activity may fall within the Guidelines if it functionally operates as one conducted with an expectation of promoting sales. A formal organizational label or stated purpose cannot justify an exemption; the content, manner, and effect on the recipient of each activity must be individually assessed.

Q（Question）

If a company's internal rules clearly stipulate that the activities of the Medical Affairs division or Medical Science Liaisons are separated from 'sales information provision activities,' may those activities be considered outside the scope of the Guidelines?

A（MHLW answer）

Whether an activity constitutes a 'sales information provision activity' is assessed and determined individually based on the actual activities conducted; therefore, the fact that internal rules stipulate a clear separation from 'sales information provision activities' does not automatically exclude those activities from the scope of the Guidelines.

So what (meaning): Internal rules separating Medical Affairs or MSL roles from sales promotion are not sufficient to achieve exemption. The actual content of each activity remains subject to individual assessment.

So why (rationale): Consistent with Q3, the regulatory principle focuses on actual activity rather than formal documentation, preventing companies from using internal rules as a shield against the Guidelines.

Commentary — background, application, practical notes

Medical Affairs (MA) and Medical Science Liaisons (MSLs) are established functions — particularly in global pharmaceutical companies — that are positioned as responsible for scientific exchange and treated as independent from the sales organization. Many companies explicitly articulate this independence in internal policies. The Guidelines, however, make clear that such institutional or documentary separation does not exempt activities from assessment on their substantive merits.

A typical scenario is an MSL hosting a webinar for physicians that introduces recent academic papers or real-world data analyses related to the company's own product. Even when the content is presented in a scientific framing, if the bulk of the information centers on data demonstrating the efficacy or usefulness of the company's own product, the actual character of the activity may be judged as sales information provision.

The practical mistake most commonly made is over-relying on a department's identity as 'scientific exchange specialists' and treating that identity as a shield against the Guidelines. When there is a gap between what the policies define and what the activity actually involves, the policy affords no protection. The existence of internal rules is not a substitute for accurately designing, reviewing, and documenting individual activities; MSL and MA activities should also be subject to materials review.

Q（Question）

Although the Guidelines state that 'raising awareness of diseases (including activities targeting the general public) is also included,' may disease awareness activities conducted for the general public that do not meet the three advertisement criteria and comply with the proper advertising standards be considered outside the scope of the Guidelines?

A（MHLW answer）

There is a risk that disease awareness activities may be used as a pretext to particularly recommend drug treatment; therefore, as explicitly stated in 2(2), such activities are within the scope of the Guidelines.

So what (meaning): General-public disease awareness activities conducted by marketing authorization holders fall within the Guidelines even if they do not meet the three advertisement criteria. Compliance with proper advertising standards alone does not provide an exemption.

So why (rationale): When pharmaceutical companies conduct disease awareness activities, there is an inherent risk of indirectly promoting drug treatment; therefore, such activities are regulated regardless of formal advertisement classification.

Commentary — background, application, practical notes

Disease awareness campaigns serve a public health purpose by encouraging patients to seek care early and obtain timely diagnoses. However, when a pharmaceutical company conducts disease awareness activity in a therapeutic area where its own product is approved, it is difficult to dismiss the underlying expectation that such activity will increase prescribing opportunities for the company's product. Even when the activity formally complies with the proper advertising standards, this does not eliminate its character as an activity conducted with an expectation of promoting sales, and it therefore falls within the Guidelines.

A typical scenario is a campaign funded and led by a pharmaceutical company that encourages the general public to undergo screening for a particular chronic disease. While the surface purpose is to promote early detection and early treatment, the activity can be understood as one that expects the company's own product to be selected once a diagnosis is established.

The point most easily misunderstood is the assumption that communications targeting the general public are assessed under a different framework from information provided to healthcare professionals. The Guidelines explicitly state that they 'include activities targeting the general public,' making no distinction based on the audience. Materials should be reviewed at the design stage to confirm that content positioned as 'disease awareness' does not cross into particularly recommending drug treatment.

Q（Question）

May information provision to healthcare professionals with whom an advisory or other outsourcing contract has been concluded be considered outside the scope of the Guidelines?

A（MHLW answer）

Whether an activity constitutes a 'sales information provision activity' is assessed and determined individually based on the actual activities conducted; therefore, the existence of an outsourcing contract with a healthcare professional does not automatically exclude the activity from the scope of the Guidelines.

So what (meaning): Even if information is provided to physicians or other healthcare professionals under an advisory or outsourcing contract, the Guidelines apply if the actual activity qualifies as sales information provision. The contractual relationship is not grounds for exemption.

So why (rationale): The principle of assessing actual activity content is applied consistently to prevent circumvention through the use of contractual frameworks to reclassify information provision as exempt 'contracted services.'

Commentary — background, application, practical notes

Advisory boards, external expert committees, and research consulting arrangements are common industry practices through which pharmaceutical companies engage healthcare professionals under formal outsourcing contracts. While these arrangements are intended to obtain scientific advice from external experts, the interpretation that information provided to such contracted parties constitutes 'sharing with an external contractor' and is therefore exempt from the Guidelines has been rejected.

A typical scenario is providing a group of physicians under advisory agreements with a 'preview' of clinical data on a new indication for the company's own product and soliciting their opinions. Even though the formal framing is one of collecting expert feedback, if the substance of the information is dominated by data favorable to the company's product, the actual nature of the activity may be judged as sales information provision.

The reason that a contractual relationship provides no basis for exemption lies in the same 'substance-over-form' principle common to Q3 and Q4. The assessment is always based on the content, purpose, and manner of each individual activity, regardless of the type of relationship involved. Information provided to healthcare professionals in advisory contexts should also ideally pass through standard materials review.

Q（Question）

Although the Guidelines state that they apply 'regardless of the method or medium of provision,' does information provision through lectures given at events organized by a marketing authorization holder, upon its request, fall within the scope of the Guidelines?

A（MHLW answer）

Even if the lecture is given by an external expert such as a healthcare professional, if the intent and purpose of the event fulfill the requirements for 'sales information provision activities' as described in 2(2), the activity falls within the scope of the Guidelines.

So what (meaning): Lectures by external experts at company-sponsored events are subject to the Guidelines if the event itself is intended to promote sales. Using external speakers does not remove the activity from regulatory scope.

So why (rationale): Using external experts to create the appearance of neutral information provision is a recognized advertisement-like tactic; the Guidelines apply based on the intent and purpose of the event regardless of who delivers the content.

Commentary — background, application, practical notes

Arranging lectures by external experts such as physicians — with the pharmaceutical company covering the costs — has been a widely used form of promotional activity. The expectation has been that a physician speaking from personal clinical experience carries a different kind of persuasiveness from promotional materials presented directly by a pharmaceutical company. The Guidelines, however, explicitly state that they apply 'regardless of the method or medium of provision,' and this Q&A confirms that such indirect formats are assessed based on the intent and purpose of the event.

A typical scenario is a company-hosted physician forum at which a physician receiving a speaking fee delivers a lecture focused on trial results supporting the efficacy of the company's own product. When the pharmaceutical company is involved in selecting the topic, framing the theme, and reviewing the slides, the entire event constitutes sales information provision activity in substance, regardless of the fact that an external physician delivers the content.

The common mistake is attempting to claim an exemption on the grounds that 'the speaker is a physician, not a company materials presenter.' Because the relevant standard is the 'intent and purpose' of the event, what matters is not who delivers the information but what objective the event is organized to serve. The entire process — from setting the topic to reviewing the lecture content — therefore needs to be managed with the same scrutiny as formal materials review.

Q（Question）

Since the Guidelines state that they apply 'regardless of title or department, to all persons employed by marketing authorization holders,' is it correct to understand that the Guidelines also apply when personnel outside the sales division conduct sales information provision activities?

A（MHLW answer）

Since the Guidelines target 'sales information provision activities,' that understanding is correct.

So what (meaning): All employees of a marketing authorization holder — regardless of their division or job title — are subject to the Guidelines when conducting sales information provision activities. Research, development, and medical affairs personnel are not exempt.

So why (rationale): To ensure regulatory effectiveness, the scope is defined by the nature of the activity rather than the organizational position of the person performing it.

Commentary — background, application, practical notes

Pharmaceutical employees who provide information to physicians and other healthcare professionals are not limited to MRs and sales representatives. Drug information staff, medical affairs employees, regulatory affairs personnel, and development team members may all have occasions to visit healthcare institutions or interact with healthcare professionals in ways that involve communicating information. The significance of this Q&A is that it makes clear the Guidelines apply uniformly across all such points of contact.

Specific examples include a drug information officer providing a detailed explanation of trial data favorable to the company's own product in response to a physician's query, or a development team member introducing the company's product's trial results in a conversation with a physician at a medical conference. In either case, the Guidelines may apply regardless of which department the employee belongs to.

From a compliance implementation standpoint, limiting education and training to the sales division is insufficient for full adherence to the Guidelines. Companies need to design compliance training that covers 'all divisions that may conduct sales information provision activities' and build internal structures that apply a materials review framework to information provided by personnel outside the sales division.

Q（Question）

Principle ① states that 'information on the indications, dosage, and administration of prescription drugs provided must be within the approved scope.' Does this mean that if the source is 'evaluation materials or review reports used in marketing approval reviews' as mentioned in principle ③, it is permissible to provide information outside the approved scope?

A（MHLW answer）

It is permissible to provide test data evaluated during marketing approval reviews or re-examinations, test data evaluated when revising package inserts, and test data that must be provided for the purpose of safety alerts regarding the company's own products.

So what (meaning): Citing review reports does not open the door to off-label efficacy claims. Only test data actually evaluated in approval, re-examination, or package insert revision processes — or data needed for safety alerts — may be shared.

So why (rationale): Principle ③ establishes the evidentiary standard (objectively evaluable and verifiable sources); it does not create an exception that permits off-label efficacy promotion simply by citing regulatory documents.

Commentary — background, application, practical notes

Principle ① (information must be within the approved scope) and principle ③ (source requirements for scientific evidence) are independent requirements. The phrase 'evaluation materials or review reports used in marketing approval reviews' in principle ③ is cited as an example of what constitutes objectively evaluable and verifiable scientific evidence; it is not an exemption that removes the restriction in principle ①. Conflating the two to reach the interpretation that 'citing review reports permits off-label provision' is not permissible.

A typical misapplication is presenting data from dosage ranges or treatment durations that were examined during the approval review process but were not ultimately approved, with the justification that they appear in review documents. Even if the data are contained in a review report, using them to promote efficacy for indications, dosages, or treatment durations outside what was approved is prohibited.

The permissible exceptions are exactly as the answer states: (1) test data evaluated in marketing approval reviews or re-examinations; (2) test data evaluated during package insert revisions; and (3) test data that must be provided for the purpose of safety alerts concerning the company's own product. Exception (3) is specifically for the purpose of issuing safety alerts — not efficacy promotion — and providing data showing that off-label dosing 'posed no problems' does not fall under (3).

Q（Question）

Principle ① states that 'information on the indications, dosage, and administration of prescription drugs provided must be within the approved scope.' Is it correct to understand that this limitation applies only to the company's own drugs?

A（MHLW answer）

That understanding is correct. However, when using data from comparative trials of the company's own drugs, it is not permissible to recommend off-label use of competitor drugs that served as comparators, concomitant drugs, prior treatment drugs, or reference drugs in such trials.

So what (meaning): The approved-scope restriction applies to the company's own products. A separate prohibition still bars recommending off-label use of competitor drugs cited as comparators or reference drugs in trial data.

So why (rationale): Restricting information on third-party drugs in the same way would overly limit legitimate scientific communication; however, using trial contexts to promote off-label use of competitor products poses patient safety risks and is therefore specifically prohibited.

Commentary — background, application, practical notes

The prohibition on providing off-label information about a company's own product is relatively straightforward to understand; however, the handling of comparative trial data that includes information about other companies' products is more complex. This Q&A confirms that the approved-scope restriction in principle ① applies only to the company's own product, while separately prohibiting the recommendation of off-label use of competitor products in the context of comparative trial data — a two-tier approach designed to prevent practical misuse.

A concrete example is citing data from a comparative trial in which the comparator drug was administered at a dose exceeding its approved dosage. While mentioning the high-dose use of the comparator may be unavoidable, presenting the data in a way that positively evaluates the off-label use of the comparator — such as implying that 'the competitor's product showed no problems at this dose' — is not permissible.

The practical point requiring attention is the handling of dosage and administration details for competitor drugs appearing as comparators, reference drugs, or prior treatment drugs in clinical trials when those details are outside their Japanese approval. This is especially important when citing overseas trial data, where the trial design may include doses that are not approved in Japan; when presenting such data, it is necessary to explicitly note that the dosage is outside the approved Japanese labeling and to use expressions that do not recommend that unapproved use.

Q（Question）

With respect to principle ①, is it permissible to present data such as increased adverse events or diminished efficacy when the drug is administered at unapproved dosages, for the purpose of issuing safety alerts?

A（MHLW answer）

If the information is necessary for the safe use of the drug and the purpose is to issue a safety alert, it may be provided. However, care must be taken to ensure that the purpose does not become one of recommending off-label use, such as showing that administration at unapproved dosages posed no efficacy or safety concerns.

So what (meaning): Safety alerts presenting risks (increased adverse events, reduced efficacy) associated with off-label dosing are permissible. Sharing data that shows off-label dosing had no problems — effectively endorsing unapproved use — is not.

So why (rationale): Safety information is essential for patient protection; however, presenting favorable outcomes for off-label use constitutes indirect promotion of unapproved use, so a clear distinction based on the purpose of the information is required.

Commentary — background, application, practical notes

Providing safety information is an essential activity for ensuring the appropriate use of drugs and protecting patients, and this naturally includes risk information associated with off-label dosages and administration methods. What this Q&A confirms is a judgment standard centered on 'whether the purpose is to issue a safety alert,' looking not only at the content of the information itself but also at whether the context, intent, and manner of its delivery function as a risk warning.

A typical permissible scenario is informing a physician that adverse event rates increase when the drug is administered at doses exceeding the approved level, framed in a context that encourages adherence to the labeled dosage. Explicitly presenting the risks of off-label dosing is properly characterized as a safety alert that supports appropriate prescribing practice.

The prohibited side of the boundary is presenting data showing that administration at off-label dosages 'raised no efficacy or safety concerns.' This is not a safety alert but an affirmation and implicit recommendation of off-label use; even when presented in the form of 'providing information,' it violates the Guidelines. Data that characterizes off-label dosing as presenting no problems is prohibited regardless of the stated purpose of the provision.

Q（Question）

Regarding principle ②, which states 'provide not only information on the efficacy of prescription drugs but also safety information including adverse reactions, and do not arbitrarily select the information provided,' is it correct to interpret this as requiring the provision of balanced and appropriate information that includes both favorable and unfavorable information?

A（MHLW answer）

That understanding is correct.

So what (meaning): Both efficacy and safety information — including adverse reactions — must be provided without arbitrarily omitting data unfavorable to the company. Selective extraction of favorable data is not permissible.

So why (rationale): Balanced information provision is essential for healthcare professionals to make accurate treatment decisions; one-sided information undermines patient safety and appropriate drug use.

Commentary — background, application, practical notes

The requirement to 'not arbitrarily select the information provided' directly targets the problem of one-sided information provision. Selecting and shaping the content of information to favor the company's own interests interferes with healthcare professionals' ability to make appropriate prescribing decisions and poses a risk of harm to patients; the principle of balanced information provision was therefore established.

Typical practical scenarios include citing multiple trial results but omitting studies where the primary endpoint showed no statistically significant difference, presenting only studies where a favorable secondary endpoint outcome was observed; or excerpting only the subgroup analysis from a meta-analysis where the overall effect size was small but a specific subgroup showed a high effect.

The misunderstanding most commonly encountered is 'there is no problem because no false information is included.' Even when each individual citation is scientifically accurate, if the overall impression created by the selection, combination, and emphasis of citations diverges from what the original papers and trial results actually show, this constitutes 'arbitrary selection of information.' In particular, the materials review process should incorporate a step that specifically checks whether the overall balance of a set of materials is faithful to the underlying evidence.

Q（Question）

Regarding principle ③, which refers to 'materials that have undergone review by a third party for appropriateness (such as peer review of academic papers),' given the history of peer review being used as a blanket endorsement and scientific standards being interpreted loosely, is it correct to understand that even peer-reviewed materials must meet the requirement of being 'subject to objective evaluation and verification by third parties'?

A（MHLW answer）

That understanding is correct. 'Peer review of academic papers' and 'evaluation materials or review reports used in marketing approval reviews' are cited as examples on the premise that they are subject to objective evaluation and verification by third parties; providing information that cannot be said to be subject to such objective evaluation and verification is not permissible.

So what (meaning): Peer review status alone does not satisfy the scientific evidence requirement. Even peer-reviewed papers must be objectively evaluable and verifiable by third parties; papers with opaque methodology or irreproducible findings do not qualify.

So why (rationale): In response to the historical pattern of peer review being treated as automatic validation, the Guidelines clarify that peer review is merely an example of third-party evaluability — the substantive requirement is objective verifiability.

Commentary — background, application, practical notes

Peer review is widely recognized as a mechanism to ensure the quality of scientific evidence, but its operation has real limitations. Cases have accumulated in which peer review did not guarantee substantive scientific validity — including situations where reviewers had conflicts of interest, where trial methods were not disclosed in sufficient detail for independent verification, and where subsequently retracted papers continued to be cited in promotional materials. Against this backdrop, this Q&A clarifies that peer review is merely 'an example of what it means for third-party evaluation to be possible,' not a sufficient condition in itself.

Scenarios that tend to be problematic include case series reports involving small numbers of patients or single-institution studies funded by the pharmaceutical company that appear in peer-reviewed journals. Even with peer-reviewed publication, if the study is not pre-registered, independent replication of the data is not possible, and research transparency has not been ensured, the requirements of principle ③ cannot be considered satisfied.

There are three practical verification points: (1) whether the trial was prospectively registered (e.g., in ClinicalTrials.gov or an equivalent registry); (2) whether the research methods are described in sufficient detail to allow replication under equivalent conditions; and (3) whether conflicts of interest among authors, the peer-reviewed journal, and the publisher are appropriately managed and disclosed. Papers that do not satisfy these criteria are not eligible for use in materials regardless of whether they have undergone peer review.

Q（Question）

Regarding principle ④, is it permissible to cite external research studies conducted before the enactment of the Clinical Trials Act and the 'Ethical Guidelines for Medical Research Involving Human Subjects' in sales information provision materials?

A（MHLW answer）

If the research satisfies principles ① through ③ and, taking into account other relevant laws and regulations, guidelines to be followed, and voluntary standards of industry associations, can be ensured to be based on scientific and objective evidence, it may be cited.

So what (meaning): Research conducted before the Clinical Trials Act was enacted may be cited in materials provided it meets principles ①–③ and its scientific and ethical reliability can be demonstrated under the laws, guidelines, and industry norms applicable at the time of the study.

So why (rationale): Rather than applying a blanket cut-off based on enactment dates of specific laws, the framework focuses on whether the research was conducted under appropriate standards of its time and meets substantive scientific validity criteria.

Commentary — background, application, practical notes

The Clinical Trials Act came into force in April 2018 and is a relatively recent law; in practice, there are many situations where data from observational and interventional studies conducted over the long preceding period become candidates for citation in materials. This Q&A establishes a framework based on the substantive standard of 'compliance with the norms applicable at the time and scientific validity,' rather than a uniform cut-off based on the date the law took effect.

A concrete verification scenario is citing results from a post-marketing surveillance study conducted in the 2000s. The Clinical Trials Act did not exist, but it is necessary to examine compliance with the GPSP Ordinance under the Pharmaceutical Affairs Act applicable at the time, as well as with the research ethics guidelines of organizations such as the Japan Medical Association, and to verify the scientific validity and objectivity of the research methods before determining whether citation is permissible.

The practical mistake most often made is the mental stop that says 'since it predates the Clinical Trials Act, there is no way to check.' Compliance with voluntary codes of the pharmaceutical industry association, research ethics guidelines issued by academic societies at the time, and relevant ministerial ordinances under the Pharmaceutical Affairs Act can be investigated through research reports, journal articles, and direct inquiries to study authors. Recording both the findings and the process of that investigation is practically important.

Q（Question）

Regarding principle ④, is it permissible to cite external research studies conducted overseas that are not subject to the Clinical Trials Act or the 'Ethical Guidelines for Medical Research Involving Human Subjects' in sales information provision materials?

A（MHLW answer）

Same as A14.

So what (meaning): Overseas research is assessed by the same standard as Q14. If the study meets principles ①–③ and its scientific and objective reliability can be demonstrated under the laws, guidelines, and industry norms of the country or region where it was conducted, citation is permissible.

So why (rationale): Applying uniform criteria of scientific validity and objective verifiability regardless of jurisdiction prevents opportunistic use of overseas data while allowing legitimate international evidence to be cited consistently.

Commentary — background, application, practical notes

Citing the results of clinical trials conducted overseas in Japanese materials is standard practice, and particularly large multinational trials and registries conducted in Europe and the United States represent important sources of evidence. This Q&A takes the position that the question is not whether Japanese law applies extraterritorially, but that 'the universal standard of scientific validity and objective verifiability applies regardless of where the study was conducted.'

A practical scenario is citing results from a Phase III trial conducted in Europe or the United States in compliance with ICH-GCP. ICH-GCP compliance is an important piece of evidence in satisfying the standards of Q14 and Q15, but whether it is sufficient requires individual assessment. The transparency of the trial design (prospective registration, protocol disclosure), the independent verifiability of the data, and the disclosure of conflicts of interest also require confirmation.

The assumption most easily made — and most easily wrong — is that 'papers published in well-known international journals inherently satisfy the criteria.' The prestige of the publishing journal is only one factor in the assessment and is not grounds for omitting verification of the trial's registration, research funding conflicts of interest, or the reproducibility of the research methods. When the regulatory environment and ethical standards of the country in question differ substantially from Japan's, additional verification becomes necessary.

Q（Question）

Regarding principle ④, since there are cases where it is not possible to determine from the literature, or it is not easy to confirm, whether external research complies with the 'Ethical Guidelines for Medical Research Involving Human Subjects,' is it correct to understand that companies are required to confirm compliance to the extent possible?

A（MHLW answer）

On the premise that principle ③ is satisfied, that understanding is correct. However, companies must be in a position to explain that they have conducted confirmation to the extent possible.

So what (meaning): When a literature source does not clearly state its ethical compliance, companies may still cite it — provided principle ③ is met and the confirmation efforts made are documented and explainable upon request.

So why (rationale): Requiring explicit ethical compliance statements in all literature would unduly restrict legitimate scientific communication; the balance struck is reasonable effort plus documented process, rather than a binary pass/fail on disclosure.

Commentary — background, application, practical notes

There are in practice many cases where a paper does not explicitly state approval by an ethics review committee or compliance with the ethical guidelines for medical research involving human subjects. This omission appears particularly in retrospective observational studies and older literature. This Q&A provides a practical answer that is neither automatic prohibition due to unconfirmability nor unconditional permission: the framework is 'reasonable confirmatory effort plus documentation.'

Concrete steps for verification include: (1) checking whether an ethics review approval number is registered in a study registry such as UMIN or ClinicalTrials.gov; (2) contacting the authors or the publishing journal; and (3) inquiring with the institutional ethics committee. If compliance cannot be confirmed after these steps are taken, the question of whether to proceed with citation becomes an individual judgment call, contingent on principle ③ (objective third-party evaluation and verification being possible) being satisfied.

The situation that most easily goes wrong is the absence of a record stating 'I checked and could not confirm compliance.' The Q&A's requirement to 'be in a position to explain that confirmation was conducted to the extent possible' means that evidence of the confirmation process itself must be maintained. In the event of a regulatory inspection or a problem arising, the inability to demonstrate what specific steps were taken to verify compliance may mean that reasonable effort is not considered to have been made.

Q（Question）

Regarding principle ④, which requires that specific conflict of interest information be 'clearly stated,' is it sufficient to record only the information that can be ascertained if the paper being cited does not include a conflict of interest disclosure?

A（MHLW answer）

This provision concerns conflicts of interest with the company itself, and confirming the provision of goods, money, labor, and other benefits by the company is a matter that should naturally be conducted. Therefore, papers for which such confirmation cannot be made should not be used.

Furthermore, for sales information provision materials that have already been prepared and are in use, the conflict of interest disclosures should be reviewed and revised sequentially.

So what (meaning): If a paper lacks a conflict of interest section, the company must still independently verify whether it provided financial or other support to the study authors. Papers where this cannot be confirmed must not be used in materials — a partial disclosure stating only 'what is known' is insufficient.

So why (rationale): A company is always in a position to know what benefits it has provided to researchers; the conflict of interest requirement is designed to ensure the integrity of third-party literature cited in promotional materials, so ignorance of one's own provision of support is not accepted.

Commentary — background, application, practical notes

The conflict of interest (COI) management requirement concerns the financial and material relationship between the pharmaceutical company and the researchers or authors, and the company itself bears the responsibility for confirming this. The absence of a COI disclosure section in a paper, or the statement that there is 'no conflict of interest,' does not eliminate the company's obligation to verify on its own. Whether the company has provided money, goods, or services to the researchers should be confirmable from the company's own accounting records and documentation, and failure to conduct this verification is not accepted.

A typical scenario is one where a physician investigator who conducted a trial using the company's own product received lecture fees, consulting fees, or research funding from the company, yet the paper's COI section is blank or states 'the authors declare no conflict of interest.' In such a case, the company's own conflict of interest with the physician can be verified through the company's payment records; relying solely on the paper's declaration to conclude there is no problem is not permissible.

The defining feature of this provision is its clear 'no' in response to the question 'is it sufficient to record only the information that can be ascertained?', going further to state that 'papers for which such confirmation cannot be made should not be used.' A strict position is adopted: if confirmation is difficult, use is prohibited. At the same time, a practical transitional measure is also required for materials already in use — that conflict of interest disclosures should be reviewed and updated sequentially.

Q（Question）

Regarding principle ②, which states that 'negative information about the efficacy, safety, and quality of prescription drugs, such as failure to demonstrate superiority, must also be provided,' what types of information are expected to be provided?

A（MHLW answer）

For example, when citing data from original research papers, information must be provided accurately without distorting the content of the original paper — which means not excerpting only the portions favorable to the company's product, but also including information such as instances where the company's product failed to demonstrate superiority and information on risks such as adverse reactions.

So what (meaning): When citing from original research, favorable excerpts alone are not sufficient. Data showing the product failed to demonstrate superiority, and information on adverse reactions and other risks, must be included so that the overall message of the original paper is accurately conveyed.

So why (rationale): Selective citation creates a distorted impression that can lead healthcare professionals to make suboptimal prescribing decisions; presenting the full context of original research is a core principle for ensuring appropriate treatment choices for patients.

Commentary — background, application, practical notes

The obligation to provide negative information is explained with more concrete specificity in this Q&A than anywhere else. What the Ministry of Health, Labour and Welfare focused on is the principle of 'not distorting the content of the original research paper.' This prohibits not only the active misconduct of fabricating data but equally the passive misconduct of manipulating the recipient's impression by selecting and emphasizing only convenient data.

A typical scenario is a randomized controlled trial comparing the company's own product against a comparator in which the primary endpoints — such as mortality and hospitalization rates — showed no statistically significant difference between groups, yet the materials present only secondary endpoint data (e.g., symptom improvement scores or changes in laboratory values) where the company's product appeared superior, omitting the primary endpoint results entirely. This selective presentation creates the false impression that the trial as a whole supports the company's product's superiority.

The point most easily misunderstood is the assumption that 'using only data that has been publicly published means there is no problem.' Even when only published data is used, the way it is selected and presented may still distort the context of the original research, and this is equally prohibited. In concrete terms, knowing that a trial exists in which the company's own product 'failed to demonstrate superiority' and then excluding that trial from the information selected for materials is precisely what constitutes 'arbitrary selection of information.'

Q（Question）

Is it permissible to have separate organizational units responsible for the review of sales information provision materials and for monitoring, each with their own responsible person?

A（MHLW answer）

It is permissible to designate separate responsible persons for review, monitoring, and other functions within the Sales Information Provision Supervisory Division.

However, even in such cases, from the perspective of clarifying accountability for sales information provision activities and ensuring consistent responses, it is necessary to clearly designate a responsible person for the Sales Information Provision Supervisory Division who oversees both functions.

So what (meaning): Dividing review and monitoring among separate persons within the supervisory division is allowed, but an overall division head who oversees both functions must be clearly designated to maintain unified accountability.

So why (rationale): While specialization through division of duties has practical merit, dispersed responsibility risks creating supervisory gaps; a single overarching responsible person ensures consistent command and accountability for the division as a whole.

Commentary — background, application, practical notes

The functions required of the Sales Information Provision Supervisory Division divide broadly into two categories: (1) advance review of materials (confirming legal compliance and scientific validity) and (2) monitoring of activities (retrospective confirmation that actual information provision was appropriate). As a company's scale increases, so does the need to have dedicated organizations and personnel responsible for each function; this Q&A clarifies two points — that division of duties is permitted, and that an overarching responsible person is mandatory.

A concrete example of an organizational structure is a division of duties in which the pharmaceutical information department handles materials review and the compliance department handles monitoring. Designating a separate responsible person for each function is permissible; however, the organization that integrates both functions as the Sales Information Provision Supervisory Division, and the overall responsible person for that integrated division, must always be clearly designated.

The practical mistake made most frequently is placing the two functions in separate departments while the responsible person who integrates them as the Sales Information Provision Supervisory Division is effectively absent or exists only as a nominal title. The substantive requirements of 'consistent responses' include having a mechanism through which problems identified in monitoring are fed back to materials review, and having a clearly established decision-making pathway in the event that a problem arises.

Q（Question）

The Guidelines state that the supervisory department for promotional information activities must be established "independently of the department in charge of promotional information activities." Is it permissible to use employees from the sales department—who are well-versed in actual sales operations—as practitioners responsible for monitoring?

A（MHLW answer）

It is preferable for practitioners carrying out monitoring work to belong to a department independent of the department in charge of promotional information activities; however, this does not preclude the supervisory department from drawing on the experience of promotional activity staff when it judges that doing so is necessary for more effective monitoring.

However, when promotional activity staff conduct monitoring work, a framework must be established that ensures proper monitoring—for example, by objectively defining monitoring procedures and evaluation criteria and by clarifying the staff member's human-resources placement within the supervisory department. Such staff are naturally expected to exercise appropriate judgment and carry out supervisory duties without being constrained by their relationship with the promotional activity department.

So what (meaning): Assigning sales veterans to monitoring roles is not prohibited, but doing so requires written, objective procedures and a clear formal placement within the supervisory department.

So why (rationale): If ties to the sales department remain, supervisory independence becomes nominal, creating a risk that inappropriate materials pass review.

Commentary — background, application, practical notes

This Q&A addresses the substantive meaning of "independence." The Guidelines require the supervisory department to be independent from the promotional department, but that independence must function not merely as a separation on an organizational chart, but as a mechanism ensuring judgment free from conflicts of interest. Using employees with sales-department experience as monitoring practitioners is not prohibited, but two structural measures are prerequisites: objective written procedures and evaluation criteria, and a clear formal human-resources placement within the supervisory department.

A typical scenario is a mid-sized pharmaceutical company with limited compliance specialists that places experienced former MR personnel—familiar with field realities—as monitoring practitioners within the supervisory department. In such cases, those individuals must be formally recorded in HR systems as members of the supervisory department, and a documented framework must exist allowing them to engage neutrally even when monitoring the sales teams they once belonged to.

A common practical error is judging independence solely by whether the monitoring practitioner physically belongs to a separate department. The three factors that actually matter are: (1) whether evaluation checklists are designed to leave no room for subjective discretion; (2) whether the practitioner's chain of command is completely severed from the sales department; and (3) whether monitoring results can be reported to the supervisory department head without sales-department pressure. Sales experience can actually enhance effective monitoring, but institutional design that enables neutral use of that experience must come first.

Q（Question）

Is it permissible to designate the Medical Affairs department as the supervisory department for promotional information activities?

A（MHLW answer）

Because whether an activity constitutes "promotional information activities" is evaluated and determined individually based on the actual activities conducted, the Medical Affairs department may itself become a department subject to supervision; therefore, designating it as the supervisory department is in principle not permissible.

However, regarding the use of Medical Affairs department employees in the work of the supervisory department—including material review—the same principles as Q20 apply.

So what (meaning): Medical Affairs cannot be the supervisory department as a rule, because its own activities may fall under the definition of promotional information activities. Individual MA staff may support monitoring under the Q20 conditions.

So why (rationale): Placing the supervised and the supervisor in the same department creates a conflict of interest that undermines the independence requirement.

Commentary — background, application, practical notes

The MHLW's explicit statement that Medical Affairs (MA) activities may fall under the definition of promotional information activities sends an important signal to the industry. MA departments claim scientific neutrality, but when their activities in practice have the effect of promoting prescriptions, the Guidelines can apply. This structural self-supervision contradiction—MA overseeing itself—is why the Guidelines prohibit designating MA as the supervisory department in principle.

A typical scenario is a pharmaceutical company attempting, in the name of cost reduction or headcount efficiency, to have its MA department concurrently serve a monitoring function. This is especially visible in cases where global headquarters directs the integration of MA and compliance functions, but any such reorganization must be assessed in advance for potential conflicts with the Guidelines' independence requirement. The only permissible use of MA personnel is to have individual specialists engage as practitioners within the supervisory department under the Q20 conditions—not to have the MA department itself bear supervisory responsibility.

A common boundary confusion is between 'MA participation in the review and supervisory committee as an advisor' and 'MA serving as the supervisory department.' MA scientific experts participating as advisors to the committee is not excluded by the Guidelines, but giving them voting rights on the committee or formal reporting obligations to the supervisory department head is a separate matter. Since MA may itself be a subject of supervision, any structure in which MA judges the propriety of its own activities must be avoided in all forms.

Q（Question）

Since there are cases where reviews of promotional materials and monitoring/guidance of promotional information activities are conducted by a collective of multiple departments and divisions to ensure appropriateness, is it permissible for each company to design its organization with discretion in line with the intent of these Guidelines?

A（MHLW answer）

It is acceptable to compose the "supervisory department for promotional information activities" by drawing on existing organizational units.

However, the organization, members, and responsible person(s) of the "supervisory department for promotional information activities" must be clearly defined.

So what (meaning): Aggregating existing departments into the supervisory function is allowed, but the composition, membership list, and named responsible person must be documented.

So why (rationale): Without clear accountability, responses to violations will be delayed and regulatory engagement will be hampered.

Commentary — background, application, practical notes

This Q&A on the organizational composition of the supervisory department confirms that the Guidelines do not mandate the creation of a new dedicated unit, but permit existing departments to be grouped together to fulfill the supervisory function. This reflects the law's focus on function rather than form, and provides a basis—particularly for smaller companies—to build compliant structures without large institutional costs.

A typical scenario is three departments—legal, regulatory affairs, and compliance—forming a 'Promotional Information Activities Supervisory Committee' that serves as the supervisory department. In this case, the organizational rules and function-allocation rules must clearly specify which officeholder among the three departments bears final supervisory responsibility, and a single contact point capable of responding to regulatory inquiries must be identified.

The practical pitfall is the risk that multi-department involvement is perceived as dispersing accountability. During regulatory guidance or corrective action proceedings, the question will be: 'Who specifically bears ultimate responsibility?' For this reason, even a multi-department structure must appoint a single 'supervisory department responsible person' whose title and name appear in internal documents and formal notifications to related departments. Nominal labels and committee formation alone are insufficient; the decision-making flow and accountability assignment must be consistent both on paper and in practice.

Q（Question）

May the review and supervisory committee be established within the company but outside the supervisory department for promotional information activities?

A（MHLW answer）

There is no objection. However, regardless of whether the review and supervisory committee is placed inside or outside the supervisory department, it is important to make full use of the committee's advice and to build a framework that appropriately incorporates a third-party perspective into monitoring and review activities.

So what (meaning): Placement outside the supervisory department is acceptable, but the procedures for incorporating committee advice into actual monitoring and review must be specified in the SOPs.

So why (rationale): A committee that exists only on paper cannot guarantee the objective oversight the Guidelines require.

Commentary — background, application, practical notes

This Q&A on the placement of the review and supervisory committee shows that the Guidelines prioritize the substantive use of the committee's advice over its formal location. Whether the committee sits inside or outside the supervisory department does not directly affect its independence or effectiveness. What matters is whether a mechanism exists to embed the committee's advice into the practical processes of monitoring and review, preventing it from becoming nominal.

A typical scenario is a company that already has a 'Compliance Committee' under the board or executive committee and incorporates the review and supervisory function within it. In such cases, the procedures must document a clear flow whereby the committee's findings lead to SOP revisions or material suspensions by the supervisory department. A practice in which advice is merely 'recorded' without translating into corrective action creates the risk that a regulatory audit will find the committee to be a formality.

A common practical failure is the committee functioning as little more than a desk exercise for incorporating third-party perspective. Committees that meet only once a year often cannot deliver advice within the timeline of material reviews, causing the review team to proceed on its own judgment. To prevent this hollowing-out, the committee's meeting frequency should be synchronized with material review and monitoring cycles, and an exception procedure for urgent advice should be defined in the SOPs.

Q（Question）

Regarding the "person with independence from the company" required as a member of the review and supervisory committee, what degree of independence is required?

A（MHLW answer）

The review and supervisory committee is expected to play a role in ensuring that reviews of promotional materials and monitoring and other supervisory guidance are conducted properly, by providing advice to the supervisory department for promotional information activities without being constrained by the interests of pharmaceutical marketing authorization holders and others. Therefore, it is necessary to carefully determine whether a "person with independence from the company" is someone who can, from the position of an outsider not bound by the interests of pharmaceutical marketing authorization holders, provide firm advice.

So what (meaning): Simply being an external person is insufficient; each candidate must be individually and carefully assessed before appointment to confirm they can give uncompromising advice free from the company's commercial interests.

So why (rationale): An advisor who tempers opinions out of deference to the company's interests renders the committee requirement meaningless and leaves inappropriate materials in circulation.

Commentary — background, application, practical notes

This Q&A on the criteria for a 'person with independence from the company' provides an important conceptual distinction: externality (being outside the company) and independence (being free from interests) are not necessarily the same thing. What the Guidelines require is the latter; the fact of not being an employee alone cannot establish independence. All economic relationships with the pharmaceutical industry, past employment, advisory contracts, and other interests must be mapped out before appointment, and the ability to provide frank advice free from those interests must be confirmed individually.

A typical scenario is evaluating a physician at a university hospital or a professor at a medical school as a committee candidate. If such individuals receive scholarship donations from the company or have served as principal investigators on clinical trials for specific products, independence concerns may arise even though they are external. Likewise, anyone concurrently serving as an advisor to another pharmaceutical company shares industry-wide interests and requires particularly careful assessment.

A common boundary error is failing to distinguish past relationships from current ones. A person who served as a consultant to the company several years ago but has since fully terminated the engagement does not have their independence permanently impaired by that past involvement. However, if the termination is recent, psychological bias may linger, so the length of the interval and the depth of past involvement should be considered holistically. Documenting the appointment assessment process allows the company to demonstrate accountability to regulators.

Q（Question）

The Guidelines state that the review and supervisory committee must include "a person with independence from the company." For example, if an external expert such as an attorney reviews promotional materials in accordance with an industry self-regulatory guideline, is it permissible to designate that person as the "person with independence from the company" required for the committee?

A（MHLW answer）

From the perspective of ensuring that the review and supervisory committee's advice to the supervisory department is conducted properly, it is not permissible for a person who performs review work on promotional materials to serve as a member of the review and supervisory committee.

Therefore, when utilizing an external expert such as an attorney who is currently conducting reviews of promotional materials as a "person with independence from the company," that person should be positioned as a member of the review and supervisory committee—not of the supervisory department for promotional information activities.

So what (meaning): An external attorney or expert who reviews materials cannot simultaneously serve as the independent member of the committee. The two roles must be held by different individuals.

So why (rationale): Advising the committee on materials one has personally reviewed constitutes self-evaluation and eliminates the objective check the committee is designed to provide.

Commentary — background, application, practical notes

The prohibition on concurrent roles as reviewer and committee member shown in this Q&A is a concrete expression of the role-separation principle required to ensure monitoring effectiveness. A person who conducted the review of materials cannot simultaneously advise the committee on the propriety of that review—the result would be self-evaluation, eliminating the third-party check. An external attorney or regulatory specialist is an 'outsider,' but as long as they serve as a reviewer, they cannot serve as an independent committee member.

A typical scenario is a pharmaceutical regulatory specialist who regularly contracts to review the company's materials, and the company wishes to draw on that expertise on the review and supervisory committee as well. The practical resolution is either to assign Person A to materials review and Person B to the independent committee role, or to limit Person A to review work and appoint a separate individual as the independent committee member. Since concurrent roles are impermissible, the organizational design must ensure a sufficient pool of qualified specialists.

A common confusion is between 'advising' on a review and 'conducting' a review. An independent committee member providing general advance advice to the review team is not problematic, but if that person specifically reviews a particular material and participates in the approval/rejection decision, they become a 'person who conducts reviews.' Even a committee member observing the review process as an 'observer' may be considered to have substantively participated in the review, so it is advisable to define clear rules in the SOPs governing contact between committee members and the review process.

Q（Question）

Can a person belonging to a global organization who is not under the supervisory authority of the Japanese subsidiary's president—for example, where the compliance department of a Japanese subsidiary belongs to a global compliance organization rather than being under the Japanese president's authority—qualify as a "person with independence from the company"?

A（MHLW answer）

Because such a person shares the same interests as a group company, they do not qualify as a person with independence, regardless of whether they are under the supervisory authority of the Japanese subsidiary's president.

So what (meaning): A global-organization compliance officer does not qualify as an independent committee member, because group-wide shared interests override the formal reporting structure.

So why (rationale): Independence means separation from the group's commercial interests as a whole, not merely from the Japanese president's chain of command.

Commentary — background, application, practical notes

This Q&A makes clear that independence is judged not by formal separation in the chain of command but by the substantive criterion of shared interests. In Japanese subsidiaries of global pharmaceutical companies, compliance functions reporting directly to global headquarters are common, but such personnel share the group's commercial interests and cannot be considered independent from the company. This Q&A directly addresses this issue arising from global organizational design.

A typical scenario is a foreign-affiliated pharmaceutical company's Japanese subsidiary designating the global Head of Compliance as a committee member. Even if that person reports to the global CEO rather than the Japanese subsidiary's representative director, independence is negated because they share the group's consolidated financial results and interests to shareholders. For the same reason, global headquarters' Medical Affairs personnel cannot serve as independent committee members.

A border case is an external attorney or former regulatory official who is formally outside the group but holds a continuous advisory contract with a group company. As long as advisory fees are paid on a continuing basis, that person's independence may be considered substantively constrained. Conversely, a truly independent third party is one who receives no remuneration or economic benefit whatsoever from the group—securing qualified candidates who meet this condition is a practical challenge for the Japanese pharmaceutical industry's governance infrastructure as a whole.

Q（Question）

Is it permissible to entrust the work of the review and supervisory committee to an appropriate external body capable of providing the necessary advice to the head of the supervisory department for promotional information activities?

A（MHLW answer）

There is no objection. However, even in such cases, responsibility for supervisory guidance concerning monitoring, review, and similar matters remains with the supervisory department for promotional information activities.

So what (meaning): Outsourcing the committee's work to a qualified external body is permitted, but the company's own supervisory department retains final accountability for monitoring and review outcomes.

So why (rationale): Regulatory responsibility cannot be transferred to a vendor; the company remains the accountable party if the external body performs inadequately.

Commentary — background, application, practical notes

This Q&A on the permissibility of outsourcing review and supervisory committee functions shows that the Guidelines treat the executing party for operations and the ultimate bearer of responsibility as separate. Operations can be delegated externally, but supervisory responsibility in the regulatory and legal sense remains with the company's own supervisory department. This principle is consistent with the general rule in Japanese corporate law and pharmaceutical administration: 'even if you outsource the work, the company retains the liability.'

A typical scenario is outsourcing committee functions to a specialized external CRO or compliance firm. Even if the contractor submits monthly monitoring reports and convenes a formal committee review semi-annually, it is the commissioning pharmaceutical company that will receive improvement directives from the regulatory authority if the contractor makes an inappropriate judgment. The outsourcing contract should therefore include the company's duty to assess and manage the quality of the contractor's work, as well as the contractor's duty to report anomalies to the company immediately.

A common mistake is assuming that outsourcing satisfies the 'committee in place' requirement while failing to monitor the contractor's actual work. Mechanisms are needed to periodically verify that the contractor is genuinely delivering advice consistent with the Guidelines' intent and that committee records are properly maintained and reported. If a problem occurs under a fully-delegated arrangement, the fact that the company did not maintain oversight is likely to count against it in regulatory proceedings.

Q（Question）

The Guidelines state that "management shall confirm whether officers and employees have engaged in appropriate promotional information activities and whether they have caused others to do so, and shall appropriately reflect this in evaluations of officers and employees." What specifically is envisaged?

A（MHLW answer）

For example, it is conceivable to set the conduct of appropriate promotional information activities—and the facilitation of such conduct by others—as a human-resources evaluation criterion for those in the department responsible for promotional information activities, thereby establishing a personnel evaluation system and compensation structure that does not rely solely on sales-maximization principles.

So what (meaning): Companies must add "appropriate promotional conduct" as an explicit criterion in performance appraisals and revise any system where only sales figures drive ratings and pay.

So why (rationale): A purely sales-driven evaluation structure creates a structural incentive for staff to provide exaggerated or misleading information, systematically encouraging guideline violations.

Commentary — background, application, practical notes

This Q&A on how management should reflect conduct in evaluations shows that the Guidelines require not merely a code of conduct for individual staff but a transformation of the organization's incentive structure itself. A personnel system that evaluates staff solely on sales volume or prescription counts structurally gives individuals a motive to provide exaggerated information. Without changing that structure, no amount of material review or SOP development will eradicate inappropriate field conduct.

A typical application is adding 'degree of compliance adherence,' 'track record of staying within approved materials,' and 'complaint handling outcomes' as quantitative and qualitative criteria in annual performance reviews. For managers—sales office heads, district managers, etc.—an additional criterion is whether they tolerated or tacitly approved subordinates' inappropriate conduct. The system must be designed so that a representative with high compliance scores can be promoted even if they miss sales targets.

A common design error is limiting compliance evaluation to 'bonus points only,' structured so that compliance scores cannot offset the negative impact of missed sales targets. Under such a system, staff are effectively forced to behave as though sales supremacy still governs them. For management to honor this Q&A's intent, 'appropriate promotional conduct' must function as an independent evaluation axis that genuinely affects promotion and compensation when rated low. Such system changes become important evidence in regulatory audits as demonstrated corrective action against a sales-first culture.

Q（Question）

Regarding monitoring of promotional information activities, are there recommended guidelines for the frequency of periodic monitoring and reporting on the status of promotional information activities to the review and supervisory committee?

A（MHLW answer）

An appropriate monitoring plan should be formulated and operated in accordance with each company's situation regarding promotional information activities, in order to ensure that appropriate promotional information activities in compliance with these Guidelines are conducted.

So what (meaning): No uniform frequency standard exists. Each company must design its own monitoring plan based on high-risk activity areas and its history of past violations, and must review that plan periodically.

So why (rationale): Because company size, product characteristics, and activity formats differ, a one-size-fits-all frequency would result in pro-forma compliance rather than substantive assurance.

Commentary — background, application, practical notes

This Q&A, which explicitly states that no target frequency exists, requires each company to develop monitoring plans using a risk-based approach. The reason for not setting a uniform standard is to avoid the risk that a one-size-fits-all frequency generates pro-forma compliance ('as long as we do it four times a year'). Company size, product characteristics, activity format, and past violation history all differ; the regulatory authority focuses on the rationality of the plan and the evidence of execution, not on frequency per se.

A typical scenario for a large company with many field representatives is developing a risk-classified monitoring plan—monthly for high-risk categories defined by region, product, or activity type, and quarterly for lower-risk categories. For smaller companies, monitoring all staff at a single uniform frequency may be the realistic approach. In either case, the planning process, implementation records, and status of corrective actions must be documented.

A common error is designing monitoring purely as a procedure for 'finding problems,' without building in linkage to how results are used—feedback, training, and SOP revision. If a problem found in monitoring is not corrected and the same issue recurs, the regulatory authority will evaluate the situation as 'monitoring is being conducted but is not functioning.' Embedding a PDCA cycle for acting on findings—synchronized with regular committee reporting—is what actually produces an effective compliance framework.

Q（Question）

Are there mandatory items that must be comprehensively covered in the standard operating procedures (SOPs) related to promotional information activities?

A（MHLW answer）

SOPs should be established in accordance with each company's situation regarding promotional information activities, including items such as the methods of promotional information activities, the creation of business records, and the handling of promotional materials, so as to ensure that appropriate promotional information activities in compliance with these Guidelines are conducted.

In addition, the items in the SOPs should be revised as necessary based on each company's operational experience.

So what (meaning): There is no fixed regulatory checklist, but activity methods, business records, and material handling are the minimum required areas; SOPs must be revised whenever actual operations change.

So why (rationale): SOPs are internal control tools for ensuring guideline compliance, and they cease to function if their content no longer reflects actual operations.

Commentary — background, application, practical notes

The absence of legally fixed mandatory SOP items might appear to mean 'anything goes,' but the three areas cited in this Q&A—activity methods, business records, and material handling—form the minimum required skeleton. In practice, supplementary provisions for monitoring procedures, complaint handling, corrective actions, and training are also expected. SOPs are the linchpin of internal control; gaps in SOPs become gaps in the supervisory function.

A typical scenario occurs when companies review existing SOPs following the Guideline's enactment and discover that while GMP-related procedures exist, there are no SOPs dedicated to promotional activities. The rational approach is to build a new SOP structure that corresponds to each provision of the Guidelines, encompassing existing 'MR Activity Manuals' and 'Materials Management Rules.' Version control of the SOPs—tracking revision history and managing the current effective version—is also a significant practical task.

A common error is treating 'creating the SOP' as fulfilling the requirement and then failing to revise it when actual operations change. For example, when new information provision formats such as electronic materials or webinars emerge, an SOP that does not cover their handling leaves practitioners without decision criteria for those new activities. The key to effective compliance is not 'creating' SOPs but 'keeping them current'; it is advisable to build in a mandatory annual review cycle.

Q（Question）

Since it is difficult to record all verbal explanations in detail in business records, is it sufficient to record information such as the date and time, the name of the visited medical institution, the names of physicians and pharmacists, and the materials used?

A（MHLW answer）

As long as explanations are provided within the scope of promotional materials that have been reviewed and approved by the supervisory department, it is acceptable to record information such as the date and time, the name of the visited medical institution, the names of physicians and pharmacists, and the materials used. However, if explanations are provided on matters not described in the promotional materials, a specific record—including an overview of the exchange with the physician or pharmacist—is required.

So what (meaning): When an MR stays strictly within approved materials, a visit log (date, facility, counterpart, materials used) is sufficient. Any explanation going beyond the materials requires a concrete record of what was said and the substance of the exchange.

So why (rationale): Off-material explanations can only be verified through records; without them, the supervisory department cannot confirm whether inappropriate information was provided.

Commentary — background, application, practical notes

This Q&A on business records for verbal explanations establishes the important principle that the required standard of documentation varies with the nature of the information provided. A visit log is sufficient when the explanation stays within approved materials, but if the explanation goes beyond those materials, a summary of the content must also be recorded. This distinction is based on the recognition that explanations outside approved materials are precisely where inappropriate information provision is most likely to occur, and ensuring that monitoring can reach those situations requires the higher record standard.

A typical scenario is a physician asking about the latest clinical trial results or off-label efficacy data not covered in the materials. Even if the practitioner provides that information in the form of 'answering the physician's question,' as long as it has not been reviewed by the supervisory department, a specific summary of the content and the exchange must be entered in the business record. This record becomes the sole basis for subsequent monitoring to assess whether inappropriate information was provided.

A frequently observed practical error is a practitioner justifying an off-material explanation on the grounds that 'the physician asked for it' while not recording it. Even if the physician requested the information, failing to record the content of the off-material explanation does not meet this Q&A's requirement. The standard for 'overview of the exchange' means sufficient specificity for a subsequent reviewer to assess the propriety of the content—a record stating 'physician had a question, provided an answer' is inadequate; the content of the question, the information provided, and its sources must be specified.

Q（Question）

Is there a recommended retention period for business records related to promotional information activities?

A（MHLW answer）

Each company should set an appropriate retention period based on its own situation, taking into account the intent and necessity underlying the requirement to create business records in these Guidelines.

So what (meaning): No minimum statutory retention period is specified in the Guidelines. Each company must set its own retention period by reasoning back from practical needs—such as the ability to respond to monitoring reviews and regulatory inquiries.

So why (rationale): If records cannot be produced during a regulatory inquiry or dispute, the purpose of keeping them is defeated; the retention period should therefore reflect real-world necessity.

Commentary — background, application, practical notes

This Q&A, which does not mandate a legally fixed retention period, leaves substantive judgment to each company, but the phrase 'taking into account the intent and necessity underlying the requirement to create records' provides an important clue. That intent is to support monitoring, respond to regulatory investigations, and prepare for legal disputes; reasoning backward from when records are needed in each of those contexts is the rational method for setting a retention period.

A typical scenario: for a company with two monitoring cycles per year, having approximately one year of records available may suffice for monitoring purposes, but regulatory investigations can take several years from initiation to final disposition, making a multi-year retention period rational from that perspective. Some companies align their retention period with the statute of limitations for administrative sanctions under the Pharmaceuticals and Medical Devices Act. The statute of limitations for tort-based civil liability (in principle three or ten years under the Civil Code) is also a practical factor to consider.

A common error is setting a uniform retention period and making it excessively short to reduce storage costs. In particular, if relevant records have been destroyed after a complaint about inappropriate information provision arises, this may raise suspicions of evidence concealment. It is therefore practically advisable to define in the SOPs an exception rule that extends retention beyond the normal period for any case involving a complaint, claim, or regulatory inquiry.

Q（Question）

Is there a prescribed method for publicly communicating the contact point that receives complaints about promotional information activities?

A（MHLW answer）

There is no objection to publicizing the contact point by any method considered appropriate in light of each company's situation.

So what (meaning): The method of communication is left to each company's discretion, but the chosen means must be practically accessible to healthcare professionals and pharmacists who may wish to file a complaint.

So why (rationale): If complaints cannot be submitted in practice, the supervisory department will remain unaware of problematic activities, so a genuinely accessible channel is the prerequisite.

Commentary — background, application, practical notes

This Q&A confirming that no particular method for publicizing the complaints contact is prescribed shows that the Guidelines care about the substance—a system through which complaints actually arrive—rather than the form of the method. A contact point that is difficult to access serves no purpose; the goal of complaint collection the Guidelines intend cannot be achieved through an inaccessible channel.

Typical approaches include providing the complaints contact address on business cards or product introduction materials distributed by practitioners at initial visits, including it in product information summaries sent to medical institutions, and posting it on web portals for healthcare professionals. In each case, a clear operational flow specifying who classifies, records, and reports complaints to the supervisory department must accompany the publicization effort.

The common practical error is establishing publicization of the complaints contact without defining the processing flow for received complaints. For the contact point to function, the following chain of processes must be documented: (1) receipt and classification of complaints; (2) identification of complaints related to promotional information activities; (3) reporting to the supervisory department; (4) implementation of corrective actions; and (5) retention of complaint records. It is also a prerequisite for effective complaint handling that the contact point staff have received training to judge whether a given submission relates to promotional information activities.

Q（Question）

If the company already has external inquiry channels such as a company website or a customer service center, is it acceptable to use those channels while ensuring that complaints related to promotional information activities are properly reported to the supervisory department?

A（MHLW answer）

There is no objection. However, care must be taken to clearly distinguish complaints related to promotional information activities from other complaints and to handle them appropriately.

So what (meaning): Reusing existing customer contact channels is acceptable, but complaints about promotional activities must be categorized separately, logged distinctly, and escalated to the supervisory department through a documented workflow.

So why (rationale): If promotional-activity complaints are mixed with general complaints, the supervisory department will not be alerted, and recurring problematic conduct will go unaddressed.

Commentary — background, application, practical notes

This Q&A permitting the repurposing of existing customer inquiry channels concedes practical convenience while imposing the substantive condition of 'handling complaints related to promotional activities distinctly from other complaints.' The purpose is to prevent the risk that complaints about promotional conduct, mixed with general product claims or adverse event reports, will fail to trigger proper escalation to the supervisory department.

A typical scenario is using an existing Medical Information (MI) department as the contact point, while designing an operational flow that identifies and records complaints about promotional activities from among received inquiries and reports them periodically to the supervisory department. The information flow between the MI department and the supervisory department must be clearly defined, with a reporting structure that enables the supervisory department to regularly receive information on the number of complaints, their content, and the status of responses.

A boundary case that commonly becomes problematic is field-level ambiguity in distinguishing 'complaints' from 'general product information inquiries.' For example, a submission stating 'the practitioner gave me incorrect information about the dosage of Drug X' should be identified as a complaint about promotional activities, not as a product information inquiry. To sharpen this identification accuracy, training for contact-point staff and a mechanism for referring doubtful cases to the supervisory department are essential. Building a double-check mechanism to prevent missed identifications into the SOPs is advisable.

Q（Question）

Is it correct to understand that Medical Representatives (MRs) may also provide information on unapproved drugs and off-label drugs?

A（MHLW answer）

The provision of information on unapproved drugs, off-label drugs, and similar products is intended to be separated from ordinary promotional information activities, and since scientific and professional validity is particularly required, it is preferable for someone other than the ordinary promotional activity representative—someone in a position to respond appropriately—to handle such inquiries. However, this does not preclude an MR from handling such inquiries in an environment separated from ordinary promotional information activities, provided that all of the conditions set out in items (1) through (8) of Part 4, Section 3 of the Guidelines are met.

So what (meaning): MR involvement is not categorically prohibited, but it is permissible only in an environment physically and organizationally separated from normal MR activities, and only when every one of the eight conditions in Part 4, Section 3 is satisfied. Failure to meet even one condition makes MR provision impermissible.

So why (rationale): Unapproved and off-label information carries high scientific complexity, and incorrect information can cause direct patient harm; the Guidelines therefore exclude this from the normal promotional framework as the default position.

Commentary — background, application, practical notes

This Q&A, which indicates that MR provision of unapproved or off-label information is 'not categorically prohibited,' simultaneously sets a high bar by making clear that it is not easily permitted. Each of the eight conditions in Part 4, Section 3 (1)-(8) of the Guidelines is an independent necessary condition; the failure of any one makes MR provision impermissible. Interpreting this Q&A as 'MRs can do it' is an error; the operational design must be oriented toward 'possible only under extremely limited conditions.'

A typical scenario arises in rare or highly specialized disease areas where Medical Affairs specialist personnel are scarce and MRs must convey scientific information to physicians. Even in such cases, the MR must provide the information in a separate setting and time completely isolated from normal visit activities; providing unapproved or off-label information as an extension of a normal MR visit is not permitted. Additionally, verification of and documentation for all eight conditions must occur before and after each such provision, and the internal procedural design to ensure this must be established in advance.

The most common boundary error is omitting verification of the eight conditions on the grounds that 'the physician strongly requested it' or 'the information was absolutely necessary for patient treatment.' Information provided without satisfying all conditions constitutes a guideline violation even if it responds to a physician's strong request. Furthermore, the interpretation of 'an environment separated from ordinary activities' requires not only physical separation (a different room, a different visit, etc.) but also organizational and documentary separation; a situation where 'the topic shifted during the same visit' does not constitute a proper separation.

Q（Question）

Is there a recommended retention period for records related to the provision of information on unapproved drugs and off-label drugs?

A（MHLW answer）

Each company should set an appropriate retention period based on its own situation, taking into account the intent and necessity underlying the requirement to create records of information provided on unapproved drugs, off-label drugs, and similar products in these Guidelines.

So what (meaning): As with Q32, no minimum statutory period is set. However, given the safety implications of unapproved and off-label information, it is practically sensible to consider retaining these records longer than ordinary business records.

So why (rationale): Regulatory and safety investigations arising from problematic provision of unapproved or off-label information can take many years; without records, factual reconstruction becomes impossible.

Commentary — background, application, practical notes

Like Q32, this Q&A sets no target retention period, but it implies that records related to unapproved and off-label information have a different character from ordinary business records. Provision of unapproved or off-label information is an exceptional act permitted only when all eight conditions are satisfied, and the record serves the function of 'proving that the conditions were met.' In regulatory investigations and legal proceedings, the existence of records is the post-hoc means of demonstrating compliance with the conditions, making a longer retention period practically required compared to ordinary business records.

A typical scenario is an MR or Medical Affairs officer handling a product in clinical trials who frequently provides unapproved or off-label information. For each individual information provision, a checklist confirming the eight conditions, the content of the information provided, and the background of the physician's request should be recorded and retained in a manner consistent with the product's approval timeline and post-marketing safety management period. If a safety issue relating to that information arises after approval, the pre-approval information provision records may be consulted.

A common error is storing 'unapproved/off-label information provision records' mixed in the same file system as ordinary business records. Because the nature of the provision differs, it is advisable to maintain a separate management system for these records. A mechanism to confirm that records remain appropriately accessible after staff transfers or resignations is also needed; specifying the storage location, responsible person, and handover procedure in the SOPs is the practical countermeasure.

Q（Question）

Should it be understood that these Guidelines also apply to the provision of information through media seminars and press releases?

A（MHLW answer）

Whether the Guidelines apply to information provided through media seminars and press releases is evaluated and determined individually based on the actual activities conducted—specifically, whether they were carried out "with the expectation of promoting sales"—and they are therefore not categorically excluded from the Guidelines' application.

In particular, when media aimed at the general public is included, there is a risk of constituting advertising directed at the general public, and a careful approach is therefore required.

So what (meaning): Media seminars and press releases are not automatically outside the Guidelines. Each activity must be assessed individually for promotional intent, and any content reaching general-public media must also be checked against consumer advertising regulations.

So why (rationale): The Guidelines apply based on substance—whether the activity was intended to promote sales—not on the format of the communication, so a formal label of 'seminar' or 'press release' provides no safe harbor.

Commentary — background, application, practical notes

This Q&A on whether the Guidelines apply to media seminars and press releases reaffirms the Guidelines' fundamental principle: judgment is based on the substantive purpose of the activity, not its form. Even a media seminar with an academic appearance or a press release claiming to be 'neutral information provision' will fall under the Guidelines if its purpose, content, and audience are evaluated as constituting an activity conducted with the expectation of promoting sales.

A typical scenario is holding a media seminar immediately after a new indication for a product receives approval, presenting the product's data to healthcare media or news services. If the content, invitees, and selection of data for that seminar are evaluated as aimed at promoting prescriptions of the specific product, the supervisory department's review is required, just as with ordinary MR activities. When a seminar includes general-public media, the conformity with consumer drug advertising regulations must also be separately verified.

A commonly confused boundary case is how to treat seminars where academic paper authors appear as presenters. Even when the presenter is an external specialist, if the company hosts and funds the event and substantively controls the content and audience, the Guidelines apply as the company's promotional information activity. For press releases, the assessment may differ between a release that reports only the factual approval information and one that includes language emphasizing the product's superiority; obtaining confirmation from the supervisory department or legal department at the drafting stage is the practical preventive measure.

Q（Question）

Part 4, Section 2 contains an item titled "Responses by Related Associations (関連団体)." What types of bodies are covered by "related associations" as used here?

A（MHLW answer）

This has in mind industry-specific associations corresponding to differences among the types of pharmaceutical products handled by businesses belonging to each association, taking into account that there are differences in the characteristics of the pharmaceutical products handled by businesses belonging to each association.

So what (meaning): "Related associations" refers to industry-specific trade associations (e.g., associations for pharmaceutical manufacturers, wholesalers, etc.). Each is expected to formulate its own member-facing compliance rules aligned with these Guidelines.

So why (rationale): Because the types of drugs handled and distribution structures differ by sector, a single set of association rules cannot practically cover the operational realities of all businesses.

Commentary — background, application, practical notes

This Q&A clarifying that 'related associations' refers to industry-specific trade associations signals that the Guidelines expect industry bodies—in addition to the direct regulation of pharmaceutical marketing authorization holders—to develop their own self-regulatory frameworks. Each sector association is expected to formulate self-regulatory guidelines and rules tailored to the operational realities of its members, providing side-channel support for member companies building compliance structures. This creates a broader industry-wide infrastructure for effective guideline implementation.

A typical scenario is a pharmaceutical manufacturers' association developing a member-facing Q&A or practical handbook explaining each provision of the Guidelines, made available as a reference for smaller member companies building their compliance frameworks. Associations for wholesalers, pharmacy chains, and generic pharmaceutical manufacturers are each expected to develop self-regulatory rules suited to the characteristics of the products their members handle. Industry-specific practical guidance tailored to sector-specific commercial practices and distribution structures serves a complementary function, addressing individual issues that the Guideline text alone cannot fully resolve.

A common error in interpretation is concluding that 'since the related association handles it, we can leave it to the association.' The Guidelines are an administrative directive that applies directly to pharmaceutical marketing authorization holders; association self-regulatory frameworks are reference and supplementary tools only. Compliance with an association's rules does not substitute for meeting the Guidelines' own requirements—a company could still be subject to administrative guidance if it fails to satisfy the core requirements. For companies spanning multiple sectors (e.g., both manufacturing and wholesaling), rules from multiple related associations may apply, and the consistency of requirements across those rules must be individually verified.