01Why split checklists by channel
The most common rework in contract production comes from one cause: an "everything checklist" that ignores how the medium behaves. The detailed citation columns built for a product monograph become noise when applied to a short-form ad. Run a patient leaflet through that same generic list and you miss the channel-specific risk that defines it — how easily a lay reader can be misled.
Seen from the regulatory side, each medium has a different layer that bites hardest. A product monograph is governed in practice by the JPMA creation guide as a format standard. A healthcare-professional website foregrounds the recording and monitoring duties of the Sales Information Provision Guidelines (MSA-G). Patient-facing materials center on Article 68 of the Pharmaceutical Affairs Act (ban on advertising unapproved drugs) and the lay-audience care provisions of the fair advertising standards. One sheet for all of it blurs which layer you are actually inspecting.
The templates here are a derivative of the four-layer framework set out in Issue 3: The Regulatory Map (Act, fair ad standards, MSA-G, JPMA) on the vertical axis, with the medium on the horizontal. If the regulatory map answers "which rules exist," this issue answers "which ones apply to this medium."
02Four channel types and their governing rules
Contract production handles dozens of material types, but bundled by how the rules apply they converge into four types. Fix this mapping at the start of every project.
| Channel type | Examples | Governing rules | Channel-specific risks |
|---|---|---|---|
| A. Monograph | Product monograph, comprehensive monograph, IF-linked material | JPMA creation guide (format) + fair ad standards + §66 | Citation sourcing, selective data extraction, figure alteration |
| B. HCP web | Product site, members-only site, eDetailing | MSA-G (record/monitor) + fair ad standards + §66 | Navigation paths, link destinations, access control, update history |
| C. Patient-facing | Disease awareness, patient explainers, medication guidance | §68 (unapproved) + fair ad standards (lay care) + disease-awareness GL | Product recall, misleading inference, fear appeal, implied efficacy |
| D. Presentation slides | Lecture slides, MR briefing material, congress assets | JPMA creation guide + MSA-G + §66/§68 | Off-label mention, omissions assuming oral support, preliminary data |
A single project routinely spans multiple types. If a product site contains a patient page, apply both the B and C columns. In practice, assign types not per material but per page or part.
03Template A: Monograph checklist
This is the domain where the creation guide governs even the format. Citation accuracy and source disclosure sit at the center of quality. Translate each provision of the 07 JPMA creation guide into columns a producer can apply mechanically.
| # | Check item | Basis | Pass criterion |
|---|---|---|---|
| A-1 | Indication and dosage match the latest approval | §66 / creation guide | Cross-checked against package insert version |
| A-2 | Cited data show source (author, journal, year, page) | Creation guide | Every graph and table has a source |
| A-3 | Figures unaltered from the original (axes, scale, arms) | Fair ad standards | Verified side-by-side with original |
| A-4 | Subgroup/post-hoc analyses marked as exploratory | MSA-G / creation guide | Limitations noted |
| A-5 | Safety stated in balance with efficacy | Fair ad standards | Serious adverse events equally visible |
| A-6 | Comparative claims backed by head-to-head trials | §66 | Indirect comparisons flagged |
From a trial that missed significance on its primary endpoint, lift only a post-hoc subgroup into the body text as "efficacy demonstrated," and exile the exploratory caveat into a footnote at the smallest font.
Present the primary endpoint result first, and state the subgroup as "an exploratory analysis that was not pre-specified and requires a confirmatory trial," at visibility equal to the body text.
04Template B: HCP web checklist
The web differs decisively from print: not just "the wording on a page" but the navigation path, link destinations, access restriction, and update management fall inside the review scope. The recording and monitoring duties of 04 MSA-G apply.
| # | Check item | Basis | Pass criterion |
|---|---|---|---|
| B-1 | HCP-only access restriction works | §68 / MSA-G | Auth/attestation gate verified |
| B-2 | External link destinations also confirmed as your responsibility | MSA-G | Destination captured and saved |
| B-3 | No path element steers toward unapproved information | §68 | Full click-path verified |
| B-4 | Update date, version, review record linked and stored | MSA-G | Update history log exists |
| B-5 | Video/interactive elements reviewed like static images | Fair ad standards | All frames and branches checked |
| B-6 | Search and social entry points don't expose unapproved info to the public | §68 | Checked in logged-out state |
B-2 and B-3 simply do not exist for print. Web review often fixes on "the wording the moment it appears on screen" and overlooks the click-path before it and the link destination after it. Fix full click-path verification into the SOP.
05Template C: Patient-facing checklist
Highest misleading risk, and Article 68 (ban on advertising unapproved drugs) comes to the front. For disease awareness, "not evoking a specific product" is the lifeline, and the lay-audience care of the fair ad standards applies in parallel. Mind the article numbers: unapproved-drug advertising is §68, exaggerated advertising is §66.
| # | Check item | Basis | Pass criterion |
|---|---|---|---|
| C-1 | Disease awareness does not evoke a specific product | §68 / disease-awareness GL | No hint of product name, color, dosage form |
| C-2 | No assertions like "cures" or "no side effects" | §66 / fair ad standards | Guarantee-type wording removed |
| C-3 | No excessive fear appeal pushing people to consult | Fair ad standards | Restraint in fear-based appeals |
| C-4 | "Consult your doctor" is substantive, not pro forma | Fair ad standards | Judgment not left to the patient |
| C-5 | Testimonials/endorsements not read as efficacy guarantees | §66 | Personal-opinion limits stated |
| C-6 | Technical terms annotated so patients don't misread | Fair ad standards | Plain-language rephrasing present |
A disease-awareness leaflet diagrams a specific mechanism and dosage form (once-weekly self-injection) and is distributed in a field where only one product fits — so it functions, in effect, as product advertising.
Present symptoms, consultation guidance, and the breadth of general treatment options without skewing to a specific mechanism or dosage form, and clearly leave the treatment choice to consultation with a physician.
06Template D: Presentation slide checklist
Slides carry a particular difficulty: "oral support is assumed." The excuse that "what the slide omits, the speaker fills in" does not hold well — once it survives as a material, review it as a self-contained expression on its own.
| # | Check item | Basis | Pass criterion |
|---|---|---|---|
| D-1 | No misleading reading on its own (not dependent on speech) | §66 / creation guide | Judged with notes hidden |
| D-2 | No off-label mention, or clearly distinguished | §68 / MSA-G | Out-of-scope clearly labeled |
| D-3 | Preliminary/un-peer-reviewed data carries limits note | MSA-G | Peer-review status stated |
| D-4 | Sources shown on the slide face (not oral only) | Creation guide | Source on each slide |
| D-5 | Difference between handout and projected versions managed | MSA-G | Version control in place |
| D-6 | Speaker's personal view distinguished from company position | MSA-G | Attribution explicit |
D-1's "judged with notes hidden" works in practice. Extract only the slide-face text, suppress the presenter notes, and read it — does it still stay within the approved scope and avoid misleading? Omissions premised on oral support become a risk once the material circulates alone after the event.
07Bundling the matrix into one SOP
Managing four templates separately leaves you hesitating at project start over which to use. In practice, fold "medium classification → template selection → merge of common + specific columns" into a single SOP.
- Classify the medium: sort the material into A–D per page or part (multiple types allowed).
- Apply common columns: first apply what's shared across all media (approval match, safety balance, source disclosure).
- Add specific columns: append per-type risks (A=citation alteration / B=navigation / C=product recall / D=oral dependence).
- Link to rules: state the basis article/rule for each item (§66/§68/creation guide/MSA-G).
- Record the verdict: keep OK/NG/needs-fix with reviewer and date (traceability is covered in Issue 10: Traceability, in preparation).
With this merge approach the common columns are maintained in one place, and only the specific columns are swapped per medium. When a checklist goes stale, the update cost drops.
08Operation: who applies it, when, at what grain
A checklist that merely exists does nothing. It works only once you decide at which gate, and by whom, it is applied. Assign the channel checklists to the four main gates of Issue 8: Gate Design (in preparation).
| Gate | Scope applied | Owner | Channel emphasis |
|---|---|---|---|
| A Concept / primary sources | Common columns (approval match, sourcing) | Production director | C=early product-recall judgment |
| B Regulatory map | Linking to applicable rules | Regulatory / supervisor | B=access-control design |
| C QC | Mechanical cross-check of all columns | QC owner | A=citation match / D=notes-hidden read |
| D QA | Sampling + re-check of judgment items | QA / separate person | C=misleading, B=click-path |
When the same person produces and finally approves, their own intent is visible to them and they underrate the misleading risk. Have the final verdict on patient-facing (C) and web navigation (B) applied by a separate person not involved in production. This follows the principle of Issue 1: The Three Layers of Quality (in preparation) — regulatory compliance is secured first among the three layers.
Templates are not fixed. When a rule is revised (an amendment to the fair ad standards, a change in MSA-G operation), update the specific columns and raise the version. The checklist itself is under version control as a traceability target.
- Change the medium and you change which rule bites. A monograph=creation guide, B web=MSA-G, C patient=§68, D slides=oral dependence — separate the channel-specific risks into per-medium columns.
- Structure the checklist with common columns (all media) and specific columns (per medium) physically apart. On a rule revision you update only the specific columns, cutting the staleness cost.
- Never confuse the articles: exaggerated advertising=§66, unapproved (pre-approval) advertising=§68, the duty of effort for information provision=§68-2. For patient-facing, §68 product-recall judgment is the lifeline.
- MHLW, "Standards for Fair Advertising of Drugs and Medical Devices" (Sep 29, 2017, Yakuseihatsu 0929 No.4). (Cross-channel expression standard)
- JPMA, "Guidelines for Preparing Prescription-Drug Product Information Summaries," latest ed. (Format standard for monographs and slides)
- MHLW, "Guidelines on Sales Information Provision Activities for Prescription Drugs" (Sep 25, 2018, Iyakuhatsu 0925 No.1). (Basis for web, recording, monitoring duties)
- JPMA, "Code of Practice," latest ed. (Activity standard including patient-facing and disease awareness)
- Yakuji Nippo, "Article-by-Article Commentary on the Pharmaceutical and Medical Device Act," latest ed. (Interpretation of §66/§68/§68-2)
- JPMA, "Considerations for Disease-Awareness Activities." (Product-recall risk in patient materials)
- MHLW, "Report of the Monitoring Program for Prescription-Drug Advertising Activities," annual editions. (Review operations and violation cases for contract production)