Q&A Collection 2 — Full Text (27 questions)

Q（Question）

When a physician or pharmacist requests information on an unapproved drug, off-label drug, or dosage not approved domestically, what information may be provided?

A（MHLW answer）

There is no objection to providing, in accordance with the conditions of the Guidelines, information that the company has determined complies with the Guidelines and may be provided.

The information provided must be accurate and based on scientific and objective evidence. Treatment guidelines, peer-reviewed original research articles, review reports and adverse event information published by overseas regulatory authorities such as the FDA and EMA, and foreign package inserts have undergone a certain level of evaluation by academic societies and overseas regulatory authorities, and can therefore serve as benchmarks for determining whether information is accurate and based on scientific and objective evidence.

For case reports, when information is requested regarding cases involving a limited number of patients, there is no objection to providing case reports as long as they are not selected arbitrarily and the limited evidence base is clearly communicated.

Negative information must be provided, including case reports.

Items requiring particular attention: (4), (5), (6), (7)

So what (meaning): If a physician or pharmacist requests it, companies may provide off-label/unapproved information that has passed internal review for Guideline compliance. Treatment guidelines, peer-reviewed articles, and FDA/EMA reports serve as evidence benchmarks; case reports may be shared with an explicit caveat on limited evidence. Negative information must always be included.

So why (rationale): A blanket ban on off-label information conflicts with legitimate clinical information needs, so provision in response to requests is permitted, provided scientific accuracy and disclosure of negative data protect patient safety.

Commentary — background, application, practical notes

Section 4-3 relaxes the previously rigid interpretation that companies could not provide any unapproved or off-label information, in recognition that off-label use is unavoidable in clinical practice. The provision makes a 'request from a healthcare professional' a necessary condition and imposes a quality requirement — that information be accurate and based on scientific, objective evidence — to draw a clear line between information provision and promotional activity. The enumeration of treatment guidelines, peer-reviewed articles, FDA/EMA review reports, and foreign package inserts as 'benchmarks for scientific grounding' reflects the intent to relax the evidentiary bar only for materials that have been evaluated by independent bodies; in-house documents not meeting those criteria require more rigorous internal assessment.

The most common scenario involves specialists in rare diseases or pediatrics — fields where domestic approvals are sparse — requesting information based on FDA review reports or international guidelines. In oncology and neurology, where multiple treatment regimens coexist, internationally standard guidelines frequently include therapies not yet approved in Japan. Providing scientifically reliable third-party materials to assist physicians in making autonomous treatment decisions is what the provision is designed to permit.

The most frequent compliance error in practice is mishandling negative information. Selectively providing only data that support efficacy — whether from case reports or journal articles — constitutes the 'arbitrary selection' prohibited by the Guidelines. A typical example is presenting a publication showing efficacy at a specific dose while omitting one that reports safety concerns at the same dose. Additionally, when providing case reports, the limitation of the evidence base must be explicitly communicated, either verbally or in writing; listing facts without stating the evidential limits does not satisfy the requirement.

Q（Question）

When a physician or pharmacist requests information on overseas efficacy, dosage, etc. not approved domestically, what information may be provided?

A（MHLW answer）

Same as A1.

So what (meaning): The same conditions as Q1 apply to information on overseas indications or dosages not approved in Japan — internal review for Guideline compliance, scientific evidence basis, and inclusion of negative information are all required.

So why (rationale): Even information approved only overseas may be relevant to domestic clinical decisions, so the same safety standards as Q1 apply.

Commentary — background, application, practical notes

A regulatory time lag between Japanese and overseas drug approvals is common across many specialties — oncology, cardiology, neurology among them. When an FDA- or EMA-approved therapy has not yet received domestic approval, physicians naturally seek information from manufacturers to inform their treatment decisions. If companies were categorically barred from providing that information, clinicians would rely solely on their own literature searches, introducing variability in information quality and interpretation. Q2 addresses this gap by permitting provision of overseas indication and dosage information under the same framework as Q1.

A typical scenario involves a specialist requesting information on a drug that is approved abroad as a first-line therapy for a given condition but lacks that same domestic approval. In such cases, FDA or EMA review reports and foreign package inserts may be provided as scientific evidence, but the fact that the indication is not approved in Japan must be explicitly stated. A document that does not make the domestic non-approval status immediately apparent — even if it is simply a copy of an overseas review report — must be supplemented with a clear notation of the domestic regulatory status.

A common misunderstanding is that publicly available overseas approval information may be shared without restriction because it is already public. However, proactively visiting a physician to explain overseas-approved uses without a prior request remains impermissible. Similarly, attaching materials on a domestically unapproved indication as supplementary reference alongside approved-use materials constitutes unsolicited provision and is prohibited — even when the drug in question holds multiple overseas approvals.

Q（Question）

When a physician or pharmacist requests information on indications or dosages whose approval was revoked as a result of re-evaluation, what information may be provided?

A（MHLW answer）

There is no objection to providing information on the fact that approval was revoked as a result of re-evaluation and the reasons for the revocation.

Items requiring particular attention: (6)

So what (meaning): Companies may inform healthcare professionals that approval was revoked and explain the reasons. They must not promote the revoked indication itself, and must comply with safety-related provision (6).

So why (rationale): Knowledge that an indication was revoked is necessary for patient safety, but providing the revoked indication itself as usable information would constitute promotion of disapproved content — hence the limitation to the fact and reason of revocation.

Commentary — background, application, practical notes

Japan's re-evaluation system re-examines previously approved drugs against current scientific standards; when an approved indication or dosage fails to meet updated requirements, the approval is revoked. Such revocation signals a regulatory judgment that the use in question should no longer continue. To prevent physicians from unknowingly prescribing for a revoked indication, providing information about the fact of revocation and the reasons for it is permissible — and from a patient-safety perspective, proactively doing so when a physician is about to rely on a revoked indication may be appropriate.

A typical scenario is a physician asking about a specific use of a long-established drug whose approval for that indication was revoked after re-evaluation, in a setting where awareness of the revocation has not yet spread throughout the clinical community. In this case, the company representative may and should convey that the indication was revoked as a result of re-evaluation and explain the regulatory grounds for that decision.

The critical boundary is the distinction between conveying the fact and reason of revocation versus providing information about the revoked indication in a way that presents it as a usable option. Even if academic publications continue to report some efficacy for the revoked indication, proactively providing such literature in a context that suggests the indication may still be viable is prohibited. Citing the trial data that led to revocation as part of explaining the decision is acceptable; providing additional publications beyond that scope in a manner implying clinical applicability is not.

Q（Question）

When a physician or pharmacist requests clinical trial data on an unapproved drug, off-label drug, or dosage not approved domestically, what information may be provided?

A（MHLW answer）

Same as A1.

However, the portion relating to case reports is excluded.

Items requiring particular attention: (4), (5), (6)

So what (meaning): Clinical trial data for unapproved/off-label use may be provided under the same conditions as Q1, but the case-report provision of Q1 does not apply here. Scientific basis and trial methodology must be clearly presented.

So why (rationale): Clinical trial data has undergone controlled-study procedures unlike case reports, so the caveat about selecting case reports non-arbitrarily and declaring limited evidence does not need to be applied separately.

Commentary — background, application, practical notes

Clinical trial data is structurally different from case reports — it is collected through scientific procedures such as randomized controlled trials and dose-escalation studies. Accordingly, the Q1 provision that case reports must be accompanied by an explicit statement of limited evidence does not apply to clinical trial data, and Q4 explicitly excludes that clause. However, the prohibitions against arbitrary selection (provision (5)) and omission of safety information (provision (6)) apply equally to trial data.

Typical scenarios include a physician at a clinical trial site requesting information on interim results of an ongoing trial for a new indication, or an inquiry about investigator-initiated trial data relevant to a planned supplemental approval. In such cases, information registered and publicly accessible in JRCT or ClinicalTrials.gov may be provided; unpublished internal analyses are outside the scope of permissible provision.

The most common practical error is providing favorable interim analysis results while withholding final data in which the primary endpoint was not met. The Q1 principle that negative information must also be provided applies equally to trial data — selectively presenting only successful outcomes from a specific trial is not permissible. Similarly, supplementing publicly registered trial information with internal analysis not yet disclosed — even when framed as 'still under internal review' — is prohibited.

Q（Question）

When a physician or pharmacist requests information on administration to pediatric patients that is not explicitly described in the package insert, what information may be provided?

A（MHLW answer）

Same as A1.

So what (meaning): The same Q1 conditions apply to pediatric use information absent from the package insert. Providing evidence-based information after internal review is permitted, and negative information must also be disclosed.

So why (rationale): Pediatric off-label use information is in high clinical demand yet often evidence-limited, so the Q1 framework of evidence requirements and mandatory negative-information disclosure is applied equally.

Commentary — background, application, practical notes

Japan's framework for mandating pediatric clinical trials is weaker than that for adults, and many drugs carry package insert language stating only that 'safety and efficacy in pediatric patients have not been established,' without specific dosing guidance. Despite this, pediatric, neonatal, and pediatric oncology settings frequently require that information, and physicians in those fields regularly turn to manufacturers for age-appropriate or weight-based dosing data. Q5 clarifies that the Q1 framework applies equally to pediatric use information absent from the package insert.

A typical request involves a physician asking for foreign pediatric society guidelines or overseas package insert data as the basis for dosing a pediatric patient with an adult-approved drug, or a physician at a center with pediatric prescribing experience asking whether the company holds internal stability or safety data for that population. The former may be provided as third-party evaluated documents under Q1's framework; the latter requires clear disclosure of scientific basis and test conditions.

The most common error is presenting limited case reports on efficacy — in a setting where pediatric evidence is sparse — without explaining the weakness of the dosing rationale or the need for safety monitoring. Adding speculative statements such as 'the safety profile is likely similar to that in adults' is also impermissible. When providing information not present in the package insert, the responsibility to clearly communicate the limits of the evidence rests with the company.

Q（Question）

When a physician or pharmacist requests information on the development status (clinical trial information) of an unapproved drug or new indication, what information may be provided?

A（MHLW answer）

For example, there is no objection to providing, in accordance with the conditions of the Guidelines, information from sites introduced on the MHLW website as 'Information on domestic clinical trials and clinical research' (University Hospital Medical Information Network (UMIN), Japan Pharmaceutical Information Center (JAPIC), Japan Medical Association Center for Clinical Trials (JMACCT)), information on clinical research conducted at medical institutions disclosed under the Clinical Research Act (Clinical Research Implementation Plan/Research Overview Publication System: JRCT), information published on the PMDA website regarding principal clinical trials and clinical trials conducted from a humanitarian perspective (expanded access trials), and information from ClinicalTrials.gov (https://www.clinicaltrials.gov/).

Items requiring particular attention: (4), (5), (6)

So what (meaning): For development status, only information already publicly registered in systems such as UMIN, JAPIC, JMACCT, JRCT, PMDA, or ClinicalTrials.gov may be provided. Unpublished internal development plans may not be disclosed verbally.

So why (rationale): Publicly registered information is independently verifiable and therefore satisfies the 'accurate, scientifically objective' requirement; undisclosed internal information cannot be verified and is therefore excluded.

Commentary — background, application, practical notes

Development-status information occupies a distinctive position because publicly registered information coexists with undisclosed internal development data. Physicians frequently ask manufacturers about ongoing trials in order to explore patient referral opportunities or gauge the timeline for new treatment options. The Guidelines limit permissible provision to information already published in public registries such as UMIN, JAPIC, JMACCT, JRCT, PMDA, and ClinicalTrials.gov — their public availability provides the objective verifiability needed to satisfy the scientific-evidence requirement.

A typical scenario involves a physician who specializes in the relevant disease area asking when a drug currently in Phase III trials for a new indication will become available or which sites are conducting the trial. In this case, the company may direct the physician to the registered trial's site listing, study design, and eligibility criteria on JRCT or ClinicalTrials.gov. What is not permissible is stating verbally that 'internally we are targeting a submission around 2028' — that is an undisclosed internal development timeline.

A common boundary error is supplementing public information with internal details in the guise of clarification. For example, after introducing a publicly registered trial summary, adding 'we are actually expecting interim analysis results soon' constitutes disclosure of non-public information. Similarly, while stating that a drug is 'under PMDA review' based on publicly available information is acceptable, describing the progress of that review or the content of interactions with the regulatory body is not, as those are internal details.

Q（Question）

When a physician or pharmacist requests quality-related information not covered by the approved specifications, such as stability of uncoated tablets in single-dose packaging, stability when crushed, or compatibility when multiple drugs are mixed, what information may be provided?

A（MHLW answer）

There is no objection to providing, in accordance with the conditions of the Guidelines, in-house materials on quality-related matters such as stability of uncoated tablets in single-dose packaging, stability when crushed, and compatibility when multiple drugs are mixed, provided the company has determined that the provision complies with the Guidelines.

When providing such information, it is necessary to take care to provide accurate information based on scientific and objective evidence, including providing data that includes test conditions and methods.

Items requiring particular attention: (4), (7)

So what (meaning): In-house quality data on single-dose packaging, crushing, or drug compatibility may be provided after internal Guideline-compliance review, but data must include test conditions and methods — results-only communication is not acceptable.

So why (rationale): Dispensing practice frequently requires quality information not in the package insert; mandating disclosure of test conditions and methods ensures the scientific transparency that allows healthcare professionals to evaluate the data appropriately.

Commentary — background, application, practical notes

Dispensing operations such as single-dose packaging, crushing, and compatibility testing fall outside approved product specifications. Depending on the formulation, enteric coatings or extended-release mechanisms can be disrupted, altering the absorption profile or causing active ingredient degradation. The absence of a 'do not crush' instruction in the package insert does not imply safety for all operations, and pharmacists frequently need company test data to determine whether a specific preparation technique is feasible at their institution. Q7 permits provision of such quality information even when it comes from in-house sources, provided test conditions and methods are disclosed.

Typical requests come from pharmacists preparing multi-drug single-dose packages for nursing home or home healthcare patients, or from compounding pharmacies seeking compatibility data when combining specific drug products. These inquiries are usually handled by the medical information department. Where no test has been conducted for a given combination, the company must honestly respond 'no data available'; speculative answers such as 'it should be acceptable' are not permissible.

The most frequent error is conveying only the conclusion of a quality test while omitting the conditions under which it was conducted — temperature, humidity, storage conditions, and measurement time points. Quality test results are highly condition-dependent: a pharmacist or physician needs to know whether a stability result obtained at 25°C/60% RH is applicable to their actual storage environment, such as a hot and humid hospital room. Providing results without conditions deprives the recipient of the information needed to evaluate applicability appropriately and does not satisfy the requirement for accurate, scientifically grounded information.

Q（Question）

When a physician or pharmacist requests information on a simple suspension method not covered by the approval, what information may be provided?

A（MHLW answer）

Same as A7.

So what (meaning): The same conditions as Q7 apply to unapproved quality information related to the simple suspension method. Information must pass internal Guideline-compliance review and be provided with test conditions and methods.

So why (rationale): The simple suspension technique is widely used for patients with swallowing difficulties, making the quality information need equivalent to Q7, so identical treatment applies.

Commentary — background, application, practical notes

The simple suspension method involves dissolving or suspending tablets or capsules in warm water for administration via syringe through a nasogastric tube or percutaneous endoscopic gastrostomy (PEG). This technique is widely used for patients requiring enteral medication delivery, but enteric-coated or extended-release formulations may undergo significant pharmacokinetic changes upon suspension — constituting use outside approved specifications. Q8 is treated as the same category as Q7: in-house stability and suspension-compatibility data may be provided together with the test conditions under which they were obtained.

Typical inquiries come from ward nurses and pharmacists managing medications for elderly patients with dysphagia or patients with impaired consciousness, or from home healthcare providers managing enteral nutrition patients. Providing data that specifies time-to-administration limits after suspension, water temperature requirements, and other test-condition parameters enables the recipient to compare those conditions against their clinical setting and make an informed judgment.

A common error is answering by analogy — for example, concluding that suspension is acceptable because a drug in the same therapeutic class is routinely suspended. Differences in formulation and excipients mean that post-suspension behavior varies between products, and analogy-based answers without product-specific test data do not satisfy the scientific-evidence requirement. Furthermore, even where in-house documents indicate that suspension is feasible, those documents must have passed an internal Guideline-compliance review before being provided to the requesting healthcare professional.

Q（Question）

For information on off-label drugs or dosages not approved domestically that is frequently requested by physicians or pharmacists, is it permissible to prepare in advance, through appropriate internal procedures, a response document that complies with the Guidelines, and to provide that document when a physician or pharmacist requests information?

A（MHLW answer）

There is no objection to preparing such a response document in advance in the described situation; however, when providing the response document in response to a request from a healthcare professional, it is necessary to confirm that the content of the document aligns with what the healthcare professional has requested.

Items requiring particular attention: (2), (3)

So what (meaning): Pre-approved response documents for frequently asked questions are permissible, but before handing one over the representative must verify that the document's content actually matches what the specific physician or pharmacist requested — mechanical distribution without checking the fit is not acceptable.

So why (rationale): Pre-preparation itself does not violate the Guidelines, but since provision of off-label information is only permitted in response to an individual request from a healthcare professional, confirmation of content alignment is required at the time of provision.

Commentary — background, application, practical notes

Medical information and scientific affairs teams sometimes prepare pre-approved standard response documents to avoid the inefficiency and quality variability of building responses from scratch for every inquiry on frequently requested off-label topics. Q9 acknowledges this operational rationale while mandating a content-alignment check at the point of use, to ensure that pre-prepared documents do not become a backdoor for unsolicited provision.

A typical workflow involves a specialist committee reviewing and approving a standard response document for an off-label use that generates dozens of inquiries annually. When an inquiry arrives, the representative verifies that the document's content actually matches what the specific physician or pharmacist asked before handing it over. Mechanically distributing the same document without performing that verification — even for inquiries on the same general topic — does not meet the requirement.

A practical difficulty arises when the inquiry differs subtly from the scope covered by the pre-prepared document. For example, if the document addresses dosing for adult patients of standard body weight but the inquiry concerns dose adjustment for a patient with renal impairment, only part of the document is relevant. In that case, the representative must either provide only the applicable sections or prepare separate information that addresses the actual question. Handing over the full document with a note to 'use the relevant parts' is not an acceptable approach.

Q（Question）

When a physician or pharmacist requests information on a treatment guideline and the treatment method recommended in that guideline includes information on off-label drugs or dosages not approved domestically, may the treatment guideline be provided?

A（MHLW answer）

There is no objection to providing the treatment guideline in accordance with the conditions of the Guidelines, provided that it is clearly communicated that the guideline contains information on efficacy, dosage, etc. not covered by domestic approval.

Items requiring particular attention: (7)

So what (meaning): Providing the full treatment guideline is permissible, but it is a mandatory precondition to clearly inform the recipient — verbally or in writing — that the guideline contains domestically unapproved indication or dosage information. After-the-fact explanation is insufficient.

So why (rationale): Treatment guidelines are important for standardizing care, but a pre-notification requirement prevents unapproved information within them from being used uncritically.

Commentary — background, application, practical notes

Treatment guidelines are authoritative documents in which academic societies systematically organize scientific evidence, forming the foundation of physicians' prescribing decisions. However, it is not uncommon for domestically unapproved drugs or dosages to be recommended as standard care in such guidelines. Unless the presence of unapproved content is made explicit when providing the full guideline, physicians may conflate those recommendations with domestically approved uses. The Q10 requirement to 'clearly communicate' this fact is specifically intended to prevent that confusion.

A typical scenario involves a specialist requesting the latest international treatment guidelines for their therapeutic area, with those guidelines including recommended regimens that have not been approved in Japan. Before providing the document, the company must clearly state something like 'Section X of this guideline contains recommendations on indications or dosages not approved domestically.' To prevent the healthcare professional from overlooking that notice, written notification — a cover note or annotation accompanying the document — is advisable in practice, rather than relying on verbal communication alone.

A common misconception is that 'the physician will assess it themselves since we handed over the full guideline.' Even if the recipient has the expertise to interpret a guideline critically, the company's obligation to proactively disclose domestic approval gaps is not waived by the physician's capabilities. Additionally, when providing only selected pages from a guideline rather than the complete document, it must be confirmed that the excerpting has not caused negative information — contraindications, safety warnings, or unfavorable recommendations — to be omitted, as this would constitute arbitrary selection in violation of provision (7).

Q（Question）

When a physician or pharmacist requests information on post-marketing surveillance results, and the company's already-published surveillance results contain information on dosages not approved domestically, may information on those surveillance results be provided?

A（MHLW answer）

There is no objection to providing the content of legally mandated reports (periodic safety reports) in accordance with the conditions of the Guidelines, provided that it is clearly communicated that the content of those reports contains information on dosages etc. not covered by domestic approval.

Items requiring particular attention: (6), (7)

So what (meaning): Legally mandated periodic safety reports (including post-marketing surveillance) may be provided with clear prior notice that they contain unapproved dosage information. Compliance with safety information requirement (6) is also mandatory — omitting safety data is not permissible.

So why (rationale): Legally mandated reports are objective documents prepared under regulatory obligation, making them easier to satisfy the scientific-objectivity requirement; the disclosure obligation regarding embedded unapproved information exists to enable appropriate evaluation by healthcare professionals.

Commentary — background, application, practical notes

Periodic safety reports and post-marketing surveillance reports are mandatory submissions prepared by companies under pharmaceutical law, reflecting the actual state of drug use in clinical practice. When off-label use exists in the real world, its inclusion in these reports is a natural consequence of accurate reporting obligations. Q11 permits provision of the content of these regulatory submissions to healthcare professionals, subject to clear disclosure that they contain off-label information.

A typical scenario involves a physician requesting safety information contained in a company's already-published periodic safety report, which records adverse events observed at dosages outside the package insert. In this case, the company may provide the full report or the relevant sections after making clear that the dosages in question are not domestically approved. The fact that the document is a legally mandated regulatory submission helps establish that the information meets the scientific-objectivity requirement.

A common error is extracting only the efficacy data from a periodic safety report while omitting the safety information — adverse event data, side effect profiles — also contained in the same document. Provision (6) makes omission of safety information impermissible; efficacy and safety information must be presented in a balanced manner. Additionally, when providing selected portions of a regulatory report rather than the full document, the company must confirm that excerpting the content out of context does not create a risk of misinterpretation by the recipient.

Q（Question）

When a physician or pharmacist requests information on a peer-reviewed original research article and that article contains information on off-label drugs or dosages not approved domestically, may the peer-reviewed article be provided?

A（MHLW answer）

There is no objection to providing the article in accordance with the conditions of the Guidelines, provided that it is clearly communicated that the article contains information on efficacy, dosage, etc. not covered by domestic approval.

Items requiring particular attention: (5), (7)

So what (meaning): Peer-reviewed articles containing off-label information may be provided, but disclosure that they include unapproved indication/dosage content is mandatory. Non-arbitrary article selection (provision (5)) and inclusion of negative articles are also required.

So why (rationale): Peer-reviewed articles are high-reliability documents that have undergone scientific scrutiny, but compliance with provision (5) on non-arbitrary selection is required to prevent companies from cherry-picking only favorable publications.

Commentary — background, application, practical notes

Peer-reviewed original research articles are primary sources that have passed editorial board scientific review — one of the document types that physicians most rely on to support clinical decision-making. As enumerated in Q1 as a benchmark for scientific grounding, peer-reviewed articles carry high evidentiary reliability. However, the risk of 'cherry picking' — where a company selectively provides articles that support a particular use while concealing contradictory publications — is inherent, and Q12 specifically requires compliance with provision (5) prohibiting arbitrary selection.

A typical scenario involves a physician requesting 'the latest evidence on efficacy at this dosage,' prompting the company to search and compile relevant peer-reviewed articles. In doing so, the company must include both articles supporting efficacy and those reporting negative results, and must explicitly communicate — verbally or in writing before provision — that the articles contain information on domestically unapproved indications or dosages. It is also desirable to be in a position to explain the selection criteria, demonstrating that no intentional filtering toward favorable outcomes was applied.

A common misunderstanding is the belief that 'providing only the articles the physician asked for is inherently non-arbitrary.' When a physician specifies a particular article by name, the concern does not arise. But when the physician makes a broad request such as 'I want to understand the evidence base for this dosing,' and the company selects which articles to provide, the selection process must be free of arbitrary bias. Additionally, in situations where a sales representative provides oral explanation alongside the literature, care must be taken to ensure that the explanation does not merge with promotional sales activity in a way that violates the separation requirement.

Q（Question）

During a meeting with a physician or pharmacist, the company determined that the healthcare professional has a strong interest in a certain therapeutic area. May the company provide information on unapproved drugs, off-label drugs, or domestically unapproved dosages related to that area even without a specific request from the physician or pharmacist?

A（MHLW answer）

Without a request from a physician or pharmacist, provision of information on unapproved drugs, off-label drugs, or domestically unapproved dosages is not permitted.

Items requiring particular attention: (2), (3)

So what (meaning): Even when a physician's or pharmacist's area of interest is known, providing unapproved or off-label information without an explicit request at that time is prohibited. This covers follow-up emails and material deliveries as well — all unsolicited provision is impermissible.

So why (rationale): A request from a healthcare professional is a prerequisite for off-label information provision; allowing companies to broaden the recipient pool at their own discretion would blur the line with promotional activities.

Commentary — background, application, practical notes

Limiting provision of unapproved and off-label information to cases where the healthcare professional has made an explicit request is the foundational requirement of Section 4-3. When a company learns a physician's area of clinical interest and proactively brings unapproved information on that topic to the next visit, the activity becomes indistinguishable from promotional outreach. Acting on the assumption that 'interest implies intent to use' and voluntarily delivering information amounts to company-initiated information dissemination — precisely what the Guidelines are designed to prevent.

A typical violation involves a physician mentioning during a meeting that patient volume for a certain condition is increasing, prompting the company representative to prepare and bring a collection of off-label use literature on that condition to the next visit 'in case it is useful.' Because the physician made no request for that material on the day it is delivered, and the company inferred the need from the earlier conversation and prepared accordingly, the delivery constitutes unsolicited provision. The same prohibition applies to follow-up emails, postal mailings, and digital content sharing.

A frequently misunderstood scenario is whether a representative may produce and provide materials during the same meeting in which a physician expressed interest. The answer turns on whether the physician made an explicit request during that meeting. Expressing interest and requesting information are distinct acts, and inferring a request from expressed interest — then voluntarily providing materials based on that inference — is not permissible. Sending follow-up 'supplementary information related to materials previously provided' without a specific new request is equally prohibited as unsolicited provision.

Q（Question）

When a physician or pharmacist requests information on unapproved/off-label drugs or domestically unapproved dosages and a peer-reviewed original article is provided in accordance with the Guidelines, may the same information be provided to other physicians or pharmacists who have not made a request to the company?

A（MHLW answer）

Without a request from a physician or pharmacist, provision of information on unapproved/off-label drugs or domestically unapproved dosages is not permitted.

Items requiring particular attention: (2), (3)

So what (meaning): Even if the same material was already provided to one healthcare professional who requested it, proactively distributing it to other non-requesting healthcare professionals is prohibited. The identity of the information does not justify wider distribution — each provision requires an individual request.

So why (rationale): Only responses to individual requests are permitted; the sameness of the information does not justify lateral distribution. Unsolicited distribution becomes indistinguishable from promotional activity and is therefore prohibited.

Commentary — background, application, practical notes

The 'individual request' requirement functions as a response to a specific healthcare professional making a specific request at a specific time. Having previously provided information to one physician does not license the company to distribute the same information to others who have not requested it. If that were permitted, companies could systematically disseminate unapproved information across an entire medical department or specialty — effectively achieving broad promotional distribution under the guise of request-response information provision.

Typical scenarios include being asked after a ward visit to 'pass the same information along to the other physicians on the team,' or attempting to distribute the same journal article to multiple physicians at a departmental meeting. In the first case, even if the original requesting physician wants the information shared, the absence of individual requests from the other physicians means it cannot be provided to them. In the second case, blanket distribution to all attendees is not permissible unless each physician present individually makes an explicit request during that meeting.

Common rationalizations — 'it is the same information, so there is no problem' and 'the physicians will share it with each other anyway' — both fail to satisfy the requirement. The identity of the information is not a qualifying condition for broader distribution. Nor is the reasoning 'physician A requested it, so I judged that providing it to physician B was also acceptable.' Each individual request is an independent event; a response to one physician does not create authority to respond on the same basis to another who has not asked.

Q（Question）

May a company provide information on off-label use or unapproved dosage regimens to a physician who has experience using the drug in that manner, even when the physician has not requested such information?

A（MHLW answer）

Unless a physician has made a request, providing information on off-label drugs or unapproved dosage regimens is not permitted.

Items requiring particular attention: (3)

So what (meaning): Even if the physician has prior off-label use experience, the company may not initiate the information provision without a request from that physician.

So why (rationale): Prior use experience does not substitute for a formal request; the request-driven principle (item 3) applies without exception.

Commentary — background, application, practical notes

This question addresses the intuitive field-level assumption that a physician with prior off-label use experience need not formally request information before receiving it. The answer is unequivocally no. The guideline makes a healthcare professional's explicit request an absolute prerequisite for providing information on unapproved or off-label drugs, and that requirement is not relaxed by the physician's personal history or attributes.

A typical scenario involves a medical representative who knows that a physician in a particular department regularly uses a drug off-label for a specific condition, and reasons that proactively sharing new evidence would be useful. Even in that situation, no unapproved-use information may be initiated by the company unless the physician personally requests it.

A common boundary error occurs when a representative opens a conversation by mentioning the physician's known off-label use practice—for example, 'I understand your department uses this drug for that condition.' That opening itself may constitute a regulated promotional approach. The physician's usage history cannot serve as a company's justification for off-label information provision, and leveraging that knowledge to prompt or steer a request is itself a compliance risk.

Q（Question）

When a physician or pharmacist requests information on unapproved drugs, off-label drugs, or unapproved dosage regimens during a discussion about treatment methods, may the company provide such information?

A（MHLW answer）

Providing information that the company has determined complies with this guideline is permissible, provided the conditions of this guideline are observed.

However, if the discussion takes place as part of the continuous flow of a sales promotional activity, the provision of information on unapproved or off-label drugs or unapproved dosage regimens must be clearly separated from the sales promotional activity.

Items requiring particular attention: (1)

So what (meaning): Responding to a mid-meeting request is allowed, but if the meeting is part of a promotional visit, the off-label information exchange must be formally distinguished from the promotional activity.

So why (rationale): Mixing approved-drug promotion with off-label information creates a misleading impression; separation is required under item (1).

Commentary — background, application, practical notes

Requests for off-label information frequently arise mid-conversation during routine promotional visits. The key contribution of this question is twofold: it confirms that such requests can be honored under the guideline's conditions, while clearly establishing that when the meeting is part of an ongoing promotional interaction, the off-label information exchange must be formally separated from the promotional activity.

When a visit is structured as a sales call for an approved product, any off-label information provided within that same interaction risks being perceived as part of the promotional message. In practice, this separation can be achieved verbally—for instance, by stating 'I will now respond to your question about the unapproved indication separately from our discussion of the approved product'—or by directing the physician to a medical information service or scheduling a distinct follow-up contact.

A common error is assuming that because the physician asked the question spontaneously, no further procedural step is needed. However, compliance depends not only on the presence of a request but also on the context in which the information is delivered. When off-label information is woven into a promotional dialogue, it can create the impression that an unapproved use is being recommended, even if unintentionally. The separation requirement exists to govern the context of the communication, not just its content.

Q（Question）

Is it permissible to use overseas clinical trial data on unapproved drugs, off-label drugs, or unapproved dosage regimens in an internal meeting—for examining domestic development—attended by physicians or pharmacists who have contracted to provide advisory opinions?

A（MHLW answer）

In the described situation, conducting such a review is permissible.

Items requiring particular attention: (1)

So what (meaning): When physicians or pharmacists attend under a formal advisory contract, an internal development meeting may include review of overseas unapproved-drug trial data.

So why (rationale): Such activity falls outside the scope of sales information provision because its purpose is development advice rather than promotion (item 1).

Commentary — background, application, practical notes

This question clarifies how the regulatory framework categorizes the involvement of external healthcare professionals in a company's domestic drug development process. When physicians or pharmacists participate under a formal advisory contract in an internal development meeting, the activity falls outside the scope of sales information provision, and sharing overseas clinical trial data on unapproved drugs in that setting is permissible.

A typical application is when a company is designing a domestic Phase II or Phase III trial for a candidate compound that has shown efficacy in global studies, and invites therapeutic-area specialists to provide input at an internal development meeting. The overseas unapproved trial data shared there supports development decision-making; its purpose is not to encourage off-label use by the attending physicians.

A critical compliance risk lies in the legitimacy and substance of the advisory contract. If the contract is nominal—designed primarily to create a pretext for delivering unapproved information—it may be viewed as a circumvention of the guideline's promotional restrictions. Contracts must reflect genuine advisory work, such as input on protocol design or patient population characteristics, and the compensation must correspond to the actual scope of advisory services provided.

Q（Question）

May a company provide information on unapproved drugs, off-label drugs, or unapproved dosage regimens to a physician or pharmacist for the purpose of co-authoring an academic journal article with a company researcher?

A（MHLW answer）

In the described situation, providing such information is permissible. However, compliance with relevant laws and regulations including the Clinical Trials Act and applicable guidelines is required.

Items requiring particular attention: (1)

So what (meaning): Co-authorship for academic publication allows sharing of unapproved drug information with a physician or pharmacist, provided the company complies with the Clinical Trials Act and related guidelines.

So why (rationale): Academic co-authorship is categorized outside sales information activity (item 1), but legal compliance obligations remain independent of that categorization.

Commentary — background, application, practical notes

Sharing unapproved drug information with healthcare professionals for the purpose of co-authoring an academic journal article is recognized as a legitimate scientific activity distinct from promotional information provision. Crucially, however, this permission is expressly conditioned on compliance with the Clinical Trials Act and other applicable laws and guidelines.

A typical co-authorship scenario involves a company researcher—often from the Medical Affairs department—leading the analysis and drafting of a manuscript based on clinical study data, with a physician or pharmacist who has clinical expertise invited as a co-author. In this context, sharing unpublished trial data and both positive and negative analytical results with the co-author is a necessary part of the collaboration and is permitted.

Two boundary errors are common. First, using a co-authorship arrangement to disguise company-driven promotional messaging in academic form—sometimes referred to as ghostwriting—is strongly condemned under the Clinical Trials Act and industry self-regulatory codes, and does not fall within the scope of this permission. Second, using the same co-authored paper as the basis for providing off-label information to other physicians who are not part of the collaboration is a separate act subject to the request-based principle. The permission granted here applies within the specific boundaries of the co-authorship itself and does not generalize beyond it.

Q（Question）

Given that the guideline requires that information provision must not involve summarizing, omitting, or emphasizing content, what should a company bear in mind when a physician or pharmacist calls its medical information center requesting information on off-label drugs or unapproved dosage regimens?

A（MHLW answer）

In such situations, the company must take care to provide not only information on efficacy and dosage but also information on safety such as adverse events, ensuring that both efficacy and safety information are appropriately conveyed.

In particular, the company must not omit safety information merely because time is limited; in such cases, alternative methods of providing information should be considered.

Items requiring particular attention: (4), (6)

So what (meaning): Telephone responses must include safety information (adverse events, etc.) alongside efficacy data; omitting safety details due to time constraints violates the guideline, and another delivery method (e.g., follow-up in writing) must be arranged instead.

So why (rationale): The prohibition on summarizing, omitting, or emphasizing (items 4 and 6) applies regardless of the communication medium; limited call time does not justify omission.

Commentary — background, application, practical notes

Telephone calls to a company's medical information center are one of the most common channels through which healthcare professionals make requests for off-label information. This question examines how the guideline's prohibition on summarizing, omitting, or emphasizing content applies in an oral, time-limited telephone setting. The answer establishes two firm requirements: both efficacy and safety information must be conveyed, and safety information may not be omitted simply because the call is time-constrained.

The most prevalent risk in telephone responses occurs when a physician or pharmacist calls with a brief, focused question—such as whether a drug is effective for a specific off-label condition—and the company representative responds with only a quick overview of efficacy evidence, leaving out adverse event profiles or patient risk factors. This constitutes an omission that violates the guideline.

The practical response to time constraints is to proactively offer an alternative delivery mechanism: for instance, sending a written summary after the call or arranging a follow-up call with adequate time. Importantly, even when the caller presses for an immediate answer, the representative is not permitted to provide an incomplete response that omits safety information. The obligation to ensure completeness overrides the caller's preference for speed, and representatives must resist being drawn into delivering a truncated response by the pace of the conversation.

Q（Question）

When a company is providing information on unapproved drugs, off-label drugs, or unapproved dosage regimens to a physician or pharmacist who requested it, and another physician or pharmacist joins and asks to receive the same information, may the company provide information to that additional person?

A（MHLW answer）

Providing information to the additionally attending physician or pharmacist who has expressed a wish to receive it is permissible, provided the conditions of this guideline are met.

Items requiring particular attention: (3)

So what (meaning): If a second healthcare professional proactively joins and requests the information, the request-based principle is satisfied and providing them with the same information is allowed.

So why (rationale): The additional attendee's expressed wish constitutes a request under item (3), so the core requirement is met regardless of the number of recipients.

Commentary — background, application, practical notes

This question addresses what happens when a third party joins an ongoing session at which unapproved drug information is being provided in response to one healthcare professional's request. The answer—that information may also be provided to the newcomer if they request it—demonstrates that the request principle is about each individual's expressed desire, not about the number of people present.

A typical scenario: a representative is explaining off-label information to Physician A, who requested it, when Physician B from the same department enters and says they would like to hear the information as well. At that moment, Physician B has made a request, so providing the same information to Physician B is permissible.

A common error involves situations where the additional person has merely been present and overheard the exchange without explicitly expressing a wish to receive the information. Passive presence—simply being in the room when the information was discussed—does not constitute a request. Care is also needed to ensure that the provision to multiple attendees does not functionally resemble an unsolicited group presentation, a concern that connects directly to Q21 (the departmental briefing scenario). The joiner's expression of interest must be active and personal—'I would like to receive this information too'—not merely incidental.

Q（Question）

During a departmental briefing on a drug attended by many physicians, if one physician asks a question about the drug's efficacy, indications, or dosage approved overseas but not domestically, may the company answer in front of the other attending physicians?

A（MHLW answer）

Providing information (answering the question) in accordance with the conditions of this guideline is permissible.

However, depending on the content of the question, the company should also consider limiting information to the minimum necessary at that time and arranging individual follow-up with the questioner at a separate opportunity.

Items requiring particular attention: (2)

So what (meaning): Answering an off-label question in a group briefing is permitted under the guideline, but for complex or sensitive content, keeping the on-the-spot answer brief and scheduling a private follow-up may be the better course.

So why (rationale): Balanced and fair information provision (item 2) requires care in public group settings; individual follow-up can better ensure completeness without creating undue influence.

Commentary — background, application, practical notes

This question extends the multi-recipient issue from Q20 into a larger, more formal setting—a departmental briefing attended by many physicians. The guideline conditionally permits answering in front of the assembled group, but the caveat that the company 'should consider limiting the response to the minimum necessary and arranging individual follow-up' is the practically critical point.

A representative scenario: during a hospital departmental briefing on a drug, a physician asks about efficacy evidence for an overseas-approved indication not yet approved domestically. The company may answer within the guideline's conditions, but if the question's content is complex, requires detailed safety information, or cannot be fully addressed without risking selective emphasis, the representative should provide only a brief on-the-spot acknowledgment and schedule a private follow-up with the questioner.

The risk inherent in group responses is that they tend toward one-way information delivery, making it difficult to tailor content to the needs of individual physicians or the characteristics of their patient populations. The representative must also explicitly state in front of the group that the information concerns an unapproved indication and clearly distinguish the response from any concurrent promotional messaging. From the fairness perspective (item 2), the representative bears responsibility for assessing whether all attendees can receive balanced and complete information in that setting—and if not, individual follow-up is the compliant path.

Q（Question）

A physician or pharmacist at a hospital department or pharmacy has requested information on unapproved drugs, off-label drugs, or unapproved dosage regimens. When that person is out and unavailable, and the company is asked to provide the information instead to another physician or pharmacist in the same department or pharmacy, may it do so?

A（MHLW answer）

Providing information in accordance with the conditions of this guideline is permissible.

However, in such cases, it is necessary to take care to confirm that the requesting physician or pharmacist and the alternative recipient are coordinating with each other regarding receipt of the information.

Items requiring particular attention: (2), (3)

So what (meaning): Delivering the information to a colleague of the absent requester is allowed, but only after confirming that the two parties have coordinated so that the substitute's receipt reflects the original request.

So why (rationale): Without coordination, the alternative recipient may not have made a genuine request in their own right, which would undermine the request principle (item 3) and the fairness requirement (item 2).

Commentary — background, application, practical notes

This question covers proxy receipt—the situation in which the person who originally requested information is unavailable, and the company is asked to deliver the information instead to a colleague in the same department or pharmacy. The answer permits this, but conditions it on confirming that the original requester and the substitute recipient are coordinating with each other regarding receipt of the information.

Typical scenarios include a physician in a hospital department saying in advance, 'If the materials arrive while I am out, please give them to my colleague,' or a head pharmacist requesting that a junior pharmacist receive information on their behalf. In both cases, the permissibility rests on the pre-existing coordination between the requester and the substitute.

The common error is when a medical representative independently decides to extend delivery to another member of the same department without being asked to do so by the original requester. If the representative selects the substitute on their own initiative, there is neither a direct request from the substitute nor confirmed coordination with the original requester, making the provision non-compliant. Coordination need not be documented in writing, but it must be confirmed in advance—after-the-fact confirmation is insufficient.

Q（Question）

When a physician or pharmacist at an exhibition booth at an academic conference requests information on off-label drugs or unapproved dosage regimens, may the company provide such information?

A（MHLW answer）

Providing information that the company has determined complies with this guideline is permissible, in accordance with the conditions of this guideline.

However, because information provision at a conference exhibition booth is generally considered part of a sales promotional activity, in such situations the company must clearly indicate that the information concerns unapproved indications, dosages, or regimens, and must provide the information in a more deliberate manner, clearly separated from the promotional activity.

Items requiring particular attention: (1), (3), (7)

So what (meaning): Booth responses to off-label requests are allowed, but because booths are inherently promotional spaces, the representative must explicitly flag the information as unapproved and visibly separate the exchange from any concurrent promotional messaging.

So why (rationale): A conference booth is presumed to be a promotional setting; without explicit labeling and separation, sharing off-label data in that context would conflate promotion and scientific information, violating items (1), (3), and (7).

Commentary — background, application, practical notes

Academic conference exhibition booths are inherently promotional settings designed to raise product awareness, meaning the entire booth environment is contextually framed as a sales information activity. This question confirms that responding to a request for off-label information in a booth is permissible, while establishing the additional procedural requirements of explicit declaration and clear separation from the promotional activity.

A typical scenario: a representative is explaining an approved product at a booth when a physician stops by and asks whether the drug can be used for an off-label condition. If the company has determined that a response is appropriate under the guideline, the representative may answer, but must explicitly state—verbally or in writing—that the information concerns an unapproved indication, and must conduct this exchange in a manner that is clearly distinguished from the ongoing promotional interaction.

Common compliance failures include booth promotional materials that inadvertently incorporate off-label data, or situations where off-label information is naturally absorbed into the promotional flow. Additionally, because conference booths are open spaces where multiple attendees may be listening, the multi-recipient issues from Q20 and Q21 can arise simultaneously. Practical mitigation strategies include conducting off-label discussions in a separate area of the booth, designating a distinct representative for such exchanges, or providing the response in writing, thereby achieving physical as well as contextual separation.

Q（Question）

When an overseas affiliate of a Japanese company hosts a lecture at which information on drugs approved abroad—covering unapproved indications or dosage regimens domestically—is presented, and a Japanese physician or pharmacist attends that lecture without any encouragement or initiative from the Japanese company, does this constitute information provision by the Japanese company on unapproved drugs, off-label drugs, or unapproved dosage regimens?

A（MHLW answer）

No, it does not.

Items requiring particular attention: (1)

So what (meaning): When Japanese physicians attend an overseas affiliate's lecture entirely on their own initiative—without the Japanese company's involvement—the information presented there is not attributed to the Japanese company as its own act of information provision.

So why (rationale): Without any active involvement or solicitation by the Japanese company, the activity cannot be classified as that company's sales or information provision activity under item (1).

Commentary — background, application, practical notes

This question resolves a grey area that arises in international corporate group structures. Specifically, it asks whether information presented at a lecture organized by an overseas affiliate of a Japanese company constitutes information provision by the Japanese company when Japanese physicians or pharmacists attend independently. The answer is no, provided the Japanese company has not actively involved itself or solicited their participation.

A plausible scenario: an overseas subsidiary hosts a product lecture at an international academic conference, presenting information consistent with that country's approved labeling. A Japanese physician attending the conference independently stops by the lecture. If the Japanese parent company has not encouraged, guided, or financially supported that physician's attendance at the lecture, the information presented there is not attributed to the Japanese company.

The 'without encouragement or initiative by the Japanese company' requirement is interpreted strictly. If the Japanese company's representative shares the lecture schedule and venue with a physician, communicates in a way that suggests they attend, or covers travel and accommodation costs premised on attendance at that lecture, active involvement can be established and the exemption ceases to apply. Independent participation in form but guided participation in substance does not qualify for this carve-out.

Q（Question）

May Medical Affairs (MA) employees of a company present clinical trial data on unapproved drugs, off-label drugs, or unapproved dosage regimens at an academic conference?

A（MHLW answer）

It is permissible for company employees to present clinical trial data at a conference that the company does not organize or co-organize, in response to a request from the conference, and in accordance with the conditions of this guideline.

Items requiring particular attention: (2), (3), (7)

So what (meaning): MA employees may present unapproved-drug trial data at a third-party academic conference, but only when the presentation is given in response to a request from the organizing academic society—not self-initiated by the company.

So why (rationale): A presentation invited by the academic society is treated as a scientific activity separate from promotion; self-initiated presentations at company-sponsored events would fall under a different assessment against items (2), (3), and (7).

Commentary — background, application, practical notes

This question clarifies the regulatory status of a Medical Affairs (MA) employee presenting clinical trial data on unapproved or off-label drugs at an academic conference. The conclusion is that such a presentation is permissible when it takes place at a conference the company does not organize or co-organize, and when the presentation is given in response to a request from the conference.

Typical scenarios include MA employees giving poster or oral presentations at domestically or internationally organized third-party academic societies. In practice, the 'request from the conference' requirement is satisfied when the academic society has invited the employee as a speaker or when an abstract has been accepted through a scientific peer review process. The presentation of clinical trial data is classified as a scientific activity aimed at disseminating knowledge, which is inherently distinct from promotional activity.

The condition 'not organized or co-organized by the company' is a frequent source of ambiguity. If a company provides financial sponsorship or co-organizes a symposium or satellite session at which its MA employee presents, the activity may be assessed as equivalent to company-organized, removing the permissibility. The fact of having received a request from the conference should be verifiable from records; an MA employee independently selecting a presentation topic because 'it is an academic venue' does not satisfy the request requirement. Additionally, the content of the presentation must reflect balanced information (item 2), and the materials used must have undergone the company's internal review process (item 7) before the presentation proceeds.

Q（Question）

When a physician or pharmacist requests a generic drug manufacturer to provide information on indications, dosage, or regimens approved for the originator drug but not for the generic due to re-examination periods, patent constraints, or other reasons, may the generic manufacturer provide such information?

A（MHLW answer）

It is permissible to inform the physician or pharmacist of the fact that the originator drug holds approval for certain indications, dosages, or regimens, while the generic drug does not.

However, providing substantive information on those indications, dosages, or regimens that only the originator drug holds approval for is not permitted.

Items requiring particular attention: (1), (4), (6), (7)

So what (meaning): A generic manufacturer may tell a healthcare professional that a given indication is approved for the originator but not for its own product; it may not go further and explain or promote that unapproved indication.

So why (rationale): Disclosing the approval gap as a fact is a neutral statement that aids prescribing decisions, whereas providing substantive off-label content would effectively promote unapproved use of the generic, violating items (1), (4), (6), and (7).

Commentary — background, application, practical notes

A 'gap indication' refers to a situation where a generic drug has not been approved for certain indications, dosages, or regimens that the originator drug holds, typically because the originator's re-examination period or patents remain in effect. For generic manufacturers, there is a clinical risk that physicians or pharmacists may prescribe the generic without awareness of the approval gap, creating a legitimate need for some form of information provision. This question establishes the boundary for how far that provision can go.

What is permitted is limited to factual notification: stating that the originator drug holds approval for a given indication while the generic does not. For example, using the package insert to explain to a physician which indications are unapproved for the generic product constitutes a factual disclosure of the gap and is permissible.

What is prohibited is going further and providing substantive information about the content of indications that only the originator holds. For instance, explaining 'the originator drug is approved for indication X, and here is the supporting evidence' amounts to providing off-label information for the generic—which the generic manufacturer's own product does not hold. In practice, when a physician asks for more detail about a gap indication, redirecting them to the originator company's medical representative is an acceptable response, but the generic company must not itself explain the unapproved indication. The distinction between disclosing the existence of the gap and explaining the content of the unapproved indication must be maintained at all times.

Q（Question）

When a patient organization requests information on the development status of unapproved drugs or new indications (clinical trial information), what types of information may the company provide?

A（MHLW answer）

For example, it is permissible to provide, in accordance with the conditions of this guideline, information from websites introduced on the Ministry of Health, Labour and Welfare website as sources of domestic clinical trial and clinical research information—namely: the University Hospital Medical Information Network (UMIN); the Japan Pharmaceutical Information Center (JAPIC); the Japan Medical Association Center for Clinical Trials (JMACCT); clinical research registered under the Clinical Trials Act in the Japan Registry of Clinical Trials (jRCT); the main clinical trials and humanitarian-use trials (expanded-access trials) published on the PMDA website; and information from ClinicalTrials.gov (https://www.clinicaltrials.gov/).

Items requiring particular attention: (4), (7)

So what (meaning): Companies may direct patient organizations to publicly registered trial databases (UMIN, JAPIC, JMACCT, jRCT, PMDA, ClinicalTrials.gov); they may not share non-public internal data or proprietary clinical results with patient groups.

So why (rationale): Restricting provision to publicly disclosed registries ensures that patient organizations receive unbiased and verifiable information, satisfying the fairness and completeness requirements in items (4) and (7).

Commentary — background, application, practical notes

This question parallels Q6—which covers clinical trial information requests from physicians and pharmacists—while extending the scope to patient organizations. Since patient organizations are not healthcare professionals and the guideline primarily governs information provision to healthcare professionals, this question is particularly important for defining the outer limits of permissible information provision to patients and the public.

What may be provided is restricted to information from publicly accessible databases maintained by authorized registries—UMIN, JAPIC, JMACCT, jRCT, PMDA, and ClinicalTrials.gov. When a patient organization asks about the development status of an unapproved drug or a new indication, the company may direct it to these public clinical trial registries in accordance with the guideline's conditions. Providing non-public internal data, proprietary clinical results, or details of the company's development strategy is not within the scope of this permission.

A common compliance failure arises when companies, motivated by a desire to be responsive to patient advocates, share non-public development updates or unpublished trial data with patient organizations. Patient organizations play important societal roles in disease awareness and policy advocacy, and companies often have strong collaborative relationships with them—but the regulatory boundary is clear: the scope of information provision to patient organizations is narrower than to healthcare professionals and is confined to publicly registered information. Because information shared with patient organizations may ultimately reach individual patients, the requirements for fairness and completeness (items 4 and 7) apply with particular force, warranting careful consideration of what is shared and how.