Alignment with the JPMA Creation Guidelines — per-medium check

01Why the owner verifies conformance to the Creation Guide

The JPMA Creation Guide is not a statute like the Pharmaceutical and Medical Device Act or the Standards for Fair Advertising. It is a self-imposed standard JPMA asks member companies to follow, prescribing in detail the conventions for product information materials, beginning with the product information summary. Precisely because it is not law, internal review treats "does it follow the guide" as the first formal gate. Wrong order, incomplete sourcing, an omitted graph axis — such defects trigger a bounce-back before the substance is even debated.

These conventions are easy to delegate to the vendor. But what is delegated is the work, not the responsibility. Of the receipt-stage verification covered in installment 3 (Receipt Flow), this piece narrows to one point: conformance to the Creation Guide. If the owner does not understand the guide's structure, they cannot judge where to look in the vendor's deliverable, and end up sending it "as is" to review.

02What the guide governs ── the top of the four layers

The norms this series relies on build up from the Act (§66 exaggerated advertising / §68 pre-approval advertising / §68-2 the duty of effort for proper information provision), through the Standards for Fair Advertising and the Sales Information Provision Guideline, to the JPMA Code and Creation Guide. The Creation Guide sits at the top — the most concrete, most detailed convention layer. For detail see the Creation Guide explainer.

The guide covers more than the product information summary. Brochures distributed in journals and at congresses, projection materials for briefings, direct mail, web-based product information — any material conveying product information to healthcare professionals falls broadly within scope. The owner's first check is "which category of the guide does this material fall under." Misclassify the category and you mistake the very conventions that apply.

03Medium changes the conventions ── a per-medium map

Even for the same clinical data, the required conventions shift with the medium. The owner's common trap is assuming "an expression approved in the product information summary can be reused as-is in a brochure or slides." In reality, the constraints and the typical deviations differ by medium.

The printed product information summary is judged strictly on item coverage and order. Congress brochures have limited space, so vendors tend to "excerpt" only the efficacy data and drop safety information or trial limitations. Projection materials lean on in-room oral explanation, so axes and n tend to be omitted. Web assets are easy to update but carry version-control risk — broken source links or stale revisions left behind. The owner receives each medium with its characteristic deviation in mind.

04Required elements and order of the product information summary

The product information summary is the core of the guide, with required items and their order prescribed. The owner's receipt verification begins by mechanically reconciling this "item coverage" and "order." Before debating quality of content, confirm there are no omissions or order violations.

1. Cover, date of creation, revision info (version identification)
2. Warnings, contraindications and other safety info (placed before or adjacent to efficacy)
3. Indications, dosage and administration (strictly matching the approval)
4. Pharmacokinetics, clinical results (sourced data, explicit trial design)
5. Adverse reactions, precautions (coverage, stated frequency)
6. Reference list, contact, internal control number

The meaning of order is not formal aesthetics. Separating safety information from efficacy and collecting it at the back makes readers more likely to take in efficacy alone. That is biased information provision, contrary to the duty of effort for proper information provision under §68-2. The owner sets "are warnings/contraindications placed adjacent to the efficacy appeal" as the key point of the order check.

05How sources are attached ── verification checklist

What the guide demands of sources is not "presence" but "traceability." Common vendor defects: source numbers assigned but not matching the reference list; data on file shown as if it were primary literature; congress abstracts treated as equal to peer-reviewed papers. The owner confirms each of the following, one by one.

• Source numbers in the body correspond one-to-one with the end reference list
• Cited data match the figures/tables of the original (no alteration or emphasis)
• Data on file, congress abstracts, and internal analyses are clearly distinguished
• No literature suggesting off-label indication/dosage is used as grounds
• For web assets, source links actually exist and the version is current

06Expression conventions ── where they break crossing media

The guide also governs expression in detail. Superlatives, assertions of safety, comparisons implying superiority over other drugs, visual exaggeration through graphs — all connect to §66 exaggerated advertising. Graphs and comparative expression break most easily when moving between media.

The owner does not relax just because an expression approved in the summary appears as-is in another medium. The deviation hides in the operations the vendor added during conversion (excerpting, slide-making, web conversion). Verification requires placing the source material and derivative side by side and reading the difference.

07Media-by-media checklist

To standardize receipt verification by medium, here is a checklist the owner keeps at hand. Weight effort toward "what breaks most" in each medium rather than reviewing every item uniformly.

The sister series "Production Quality Management" (Production Quality Management) covers how the vendor builds these conventions in. The owner's check and the vendor's build are a pair. Sharing this list with the vendor in advance raises the level of pre-delivery self-inspection and cuts bounce-back round trips.

08Decision and record ── the owner's judgment template

Verification completes with decision and record. "I looked" is not discharging the responsibility. Judge the media-by-media results in three tiers — conforms / conditional / non-conforming — and leave the grounds. Bind the following template into the receipt record.

• Material ID / media category: which division under the guide
• Order: conforms / non-conforming + location (pages with omission or order violation)
• Source: conforms / non-conforming + citation numbers that could not be reconciled
• Expression: conforms / conditional / non-conforming + the expression and its guide grounds
• Overall decision: send to internal review / return to vendor / hold
• Reviewer, date, guide version referenced

Keeping a conditional tier available avoids full bounce-back round trips over minor fixes. But when sending to internal review conditionally, record the unmet items and a correction deadline. Record format and retention are covered in installment 10 (Documentation (in preparation)). The media-by-media decision is the evidence that later explains "why this material was passed," and the owner's final move for making responsibility visible.