The "Creation Guide" is, in full, the "Creation Guide for Product Information Summaries and Related Materials for Prescription Drugs." It is a practical manual compiled by the Review Committee for Prescription Drug Product Information Summaries of the JPMA (Japan Pharmaceutical Manufacturers Association), and is informally called the "tora-no-maki" (the field handbook). First issued in 2015, it was revised in 2017, 2019 and other years, and the current version dates from October 2023. This page is the hub: an overview and the entrance to each layer beneath it.
In one sentence, the Guide translates higher-level norms into the concrete question of "how do you actually build the material?" Around promotion sit the Fair Advertising Standards, behind them the JPMA Code, and behind those the Pharmaceuticals and Medical Devices Act. These set out the principles of what is and is not allowed, but the moment you try to produce a single brochure, slide, or web asset, countless situations arise that the principles alone cannot resolve. The Guide steps into that gap and gives direction down to the level of required items, ordering, type size, and the conventions for charts and tables.
This site does not reproduce the text of the Guide. The original forbids unauthorized copying, so what follows re-edits the intent and meaning of each provision. When you build real materials, always consult the latest original.
01Three Parts ― Chapters Divided by the Nature of the Medium
The Guide is split into three large parts, and the arrangement has a reason. The single demand "accurate, and not misleading" must be kept in different ways as the nature of the medium changes. A booklet with generous space and a single-page advertisement that strips everything down differ both in how required items can be lost and in how emphasis takes effect.
| Part | Scope | Character |
|---|---|---|
| Ⅰ Product Information Summary | The core material conveying each product to healthcare professionals | The heart of the Guide. The comprehensive version covers 16 items in a fixed format and order |
| Ⅱ Advertising in (print) professional journals | Ads in professional journals for healthcare professionals (including congress programs, company publications, and web postings) | Divided by content into ordinary ads, brand-name ads, and editorial-style ads |
| Ⅲ Other materials | Materials that fall under neither of the above (11 chapters in all) | Chaptered by medium. Anything unregulated is judged by the higher norms |
Chaptering by the nature of the medium is the structural signature of the Guide. Slides, lecture records, congress-venue posters, notification documents, disease explanations, patient-facing materials, product lists, compatibility tables, congress abstract collections, article reprints, and literature abstract collections ― Part Ⅲ divides these into eleven chapters, each with its own conventions.
02The Foundation ― The Spirit of the Foreword and the Discipline of Science
Above the three parts sits an unwritten "foundation": the Guide's foreword, "Introduction," and the scientific discipline it presupposes. From the hub, before plunging straight into Part Ⅰ, it is best to step onto this foundation first. Once you grasp why something is demanded, each provision reads not as a rule to memorize but as a coherent requirement.
The foreword is the constitution of the whole Guide
The foreword is short, but it concentrates the principles that run through everything. Companies have a duty to convey accurate information to healthcare professionals. Conveying it without misleading matters. And there is a decisive phrase ― the basis of proper-use information is, above all, the package insert, and the product information summary and related materials merely "supplement" it.
The word "supplement" carries weight. The product information summary ranks beneath the package insert, and the original is the approved content itself. So a material cannot exceed the scope of approval by a single character. However clever the device that makes a drug look effective, the instant it steps outside approval it becomes a violation.
"Not misleading" is a duty distinct from "not lying"
The foreword says "accurate and not misleading." This should be read as a requirement separate from "do not lie." Even if every individual datum is true, if the way it is shown forms a false picture in the recipient's mind, that is a violation. True, yet misleading ― closing this gap is the motive behind the Guide's fine-grained rules for charts and tables.
Not exhaustive, yet not a license
The foreword admits one more important thing: the Guide states basic matters and does not cover everything. But "not written down" does not mean "permitted." Even unregulated materials remain subject to the Pharmaceuticals and Medical Devices Act, the Fair Advertising Standards, the Guidelines for Sales Information Provision Activities, and the JPMA Code. The foreword itself forecloses using the Guide as an answer key.
The discipline of science ― why evidence has a hierarchy
Materials handle clinical data, so reading the Guide requires knowing how the underlying evidence is judged. Evidence has a hierarchy of quality. Meta-analyses and systematic reviews sit at the top, followed by randomized controlled trials (RCTs), then observational studies (cohort, case-control), case reports, and finally expert opinion and review articles. Whether something has been peer-reviewed is the watershed of quality. In vitro and animal data must not be linked directly to clinical effect, because of differences in species, dose, and system.
The vocabulary of trial design appears throughout the Guide. Randomization evens out known and unknown biases. Double-blinding removes the bias of expectation and subjectivity. A control is placed to measure absolute effect (placebo) or relative position (active comparator). And confirmatory trials (testing one pre-specified hypothesis) and exploratory trials (searching for hypotheses) carry entirely different weight in their results.
Statistical significance is not the same as clinical meaning. A p-value only states the probability of seeing this difference by chance assuming there is no difference; it says nothing about the size of the effect or its clinical value. In large trials even a tiny difference can be significant, and "no significant difference" does not mean "equivalent." A 95% confidence interval shows the precision ― the range in which the effect likely falls. A hazard ratio is therefore properly read together with its confidence interval and the absolute difference.
Three pillars that run underneath
The design philosophy beneath the foundation reduces to three pillars. First, close off "true but misleading" expression. Second, implement balance ― in concrete forms such as the type size of safety information, citing source pages, and capping reference information at a quarter of the whole. Third, secure verifiability through structure ― leaving sources, statistical methods, and the date of creation or revision so that anyone can trace them later. Safety must be disclosed even when it is unfavorable to the company. This is a duty of disclosure asymmetric with efficacy.
03How to Descend ― Using This Hub
This site is built to start from the foundation and descend into Parts Ⅰ, Ⅱ, and Ⅲ. The recommended order is as follows.
- Read the foundation first. With the spirit of the foreword and the discipline of science in hand, the later provisions enter your head together with their "why."
- To Part Ⅰ, Product Information Summary. Descend through Chapter 1 (basic considerations that apply to all materials), Chapter 2 (the comprehensive summary's 16 items), and Chapter 3 (the specific-item summary).
- To Part Ⅱ, journal advertising. See how the thinking that is continuous with the product information summary is kept within the narrow space of an ad.
- To Part Ⅲ, other materials. Find which chapter your material falls under and check its specific conventions. If it fits no chapter, return to the foundation and judge.
As related higher-level norms, it helps to consult the Fair Advertising Standards and the JPMA Code alongside this Guide. Since the Guide translates those principles into practice, returning to the principles clarifies the reasoning when you are unsure.
The Creation Guide is not a rulebook of prohibitions lined up in rows. It is a handbook that translates the single demand "accurate, and not misleading" ― medium by medium, item by item ― down to type size and the conventions of charts and tables. The three-part structure is the map of where that demand is translated to; the foundation is the principle of the translation itself.
When a single provision puzzles you, return to the spirit of the foreword: the package insert is the original and the material is only a supplement; the duty is not only to avoid lying but to avoid misleading; and even without a written rule, the higher norms still govern. Most of the seeds of the answers lie there. Next, step onto the foundation, then descend from Part Ⅰ.