When practitioners in materials production find themselves uncertain about the source of a particular requirement, that uncertainty usually traces back to an incomplete picture of the layered norm structure. There is a law — the Pharmaceutical and Medical Device Act. Above the Creation Guide sit administrative standards and guidelines. There is an industry self-regulatory code. The Creation Guide itself is the practical implementation at the operational level. And for certain materials, a separate voluntary agreement on RMP displays adds another layer of obligation. These do not coexist as equals; they are stacked in a hierarchy.
Understanding the hierarchy has two concrete benefits. First, when the Creation Guide is silent, it becomes clear where to look next. Second, it prevents conflating what each norm is responsible for. Without knowing that the PMD Act may prohibit what the Creation Guide does not address, a practitioner may read the Guide's silence as permission.
01The four-layer structure
The norms relevant to materials production can be organized into four layers. The table below maps the full structure.
| Layer | Name | Character | Role | Consequence of violation |
|---|---|---|---|---|
| Layer 1 | Pharmaceutical and Medical Device Act (PMD Act) | National statute | Sets the uppermost regulatory boundary: prohibits exaggerated advertising and claims of unapproved indications | Administrative disposition; criminal liability |
| Layer 2 | Standards for Fair Advertising of Drugs and Other Products Guidelines for sales information provision activities (sales information guidelines) |
Administrative standard; administrative guideline | Translates the intent of the PMD Act into operational practice for advertising and information provision. Defines standards for expression, balance, and conduct | Administrative guidance; corrective request |
| Layer 3 | JPMA Code of Practice (JPMA Code) | Industry self-regulation | Voluntary code of conduct governing relationships with healthcare professionals. Extends the principles of Layers 1 and 2 across the industry through self-governance | Voluntary sanctions and public disclosure by JPMA |
| Layer 4 | JPMA Creation Guide for Prescripton Drug Product Information | Industry operational guide | Translates the principles of the upper three layers into specific guidance for materials production. Focuses on fundamental matters for day-to-day implementation | Industry-level identification and correction |
02The role of each layer and how they relate
Layer 1: PMD Act — the statutory foundation
The PMD Act provisions most directly relevant to materials production are the prohibition of exaggerated advertising (Article 66) and the prohibition of advertising unapproved efficacy, effectiveness, or performance (Article 68). These apply regardless of what the Creation Guide says. The principle that materials may only describe indications and dosage within the approved scope derives not from the Guide but from the PMD Act itself.
The PMD Act, as a national statute, establishes the uppermost regulatory boundary. No industry norm or voluntary code can authorize conduct that falls outside this boundary.
Layer 2: Administrative standards and guidelines — bridging law and practice
The PMD Act establishes principles, but the law's text alone makes it difficult to determine what "exaggerated" means in specific cases or what "appropriate information provision" requires in practice. Standards for Fair Advertising and the sales information guidelines serve that bridging function.
Standards for Fair Advertising provides administrative interpretive criteria for the expression used in advertising. The sales information guidelines reach further, covering information provision through MRs in addition to written materials, and specifying what appropriate conduct looks like across the full range of provision activities. Neither is a statute, but both are issued under MHLW notification and carry practical binding force.
Layer 3: JPMA Code — industry self-discipline
The JPMA Code is a code of conduct that member companies have voluntarily established. It addresses areas that law and administrative guidance do not fully cover: gifts and entertainment to healthcare professionals, the conduct of information provision, relationships with patient organizations, and related ethical standards. There are no statutory penalties for violations, but member companies are expected to comply, and failures are handled through industry-level mechanisms.
Layer 4: Creation Guide — the operational handbook
The Creation Guide translates the principles of the three layers above it into guidance for the specific situations of materials production: product information summaries, supplementary materials, and materials carried by MRs. The foreword's phrase "defines fundamental matters" captures this position accurately. The Guide is not a substitute for the upper layers; it provides operational-level direction based on those layers.
03The RMP display voluntary agreement — a separate obligation
Beyond the four-layer structure, certain materials carry an additional obligation. Materials created for additional risk minimisation activities under a Risk Management Plan (RMP) must include the displays specified in the voluntary agreement dated 5 June 2017 (JFPA Notification No. 367).
This display obligation sits outside the Creation Guide. Complying with the Guide is not sufficient for materials that fall within the RMP scope — those materials also require verification against the voluntary agreement. The foreword makes this explicit to prevent the misreading that consulting the Creation Guide alone is enough.
Verifying whether a material is subject to RMP requirements must not be skipped. When a product's RMP includes additional risk minimisation activities, the relevant materials must include the displays specified in the agreement — for example, language indicating that the material forms part of the RMP-based safety programme. The Creation Guide contains no provision on this point, so a Guide-only review will miss it.
04Using the hierarchy to form judgments
This layered structure provides a sequence of inquiry. When a question arises about a particular material or expression, the following order applies.
Start at Layer 4: does the Creation Guide provide a specific provision? If so, that is the first reference point. If not, move up.
Check Layer 3: does the JPMA Code address the matter? Questions related to the propriety of information provision or relationships with healthcare professionals are examined here.
Check Layer 2: does the matter raise concerns under Standards for Fair Advertising or the sales information guidelines? This is where questions about exaggeration, balance, and the context of information provision are examined.
Check Layer 1: does the conduct risk violating the PMD Act's prohibitions? Indications outside the approved scope and exaggerated advertising connect directly to statutory violations.
This sequence does not end when one layer yields an answer. Completing the check across all layers is what constitutes a complete judgment.
The layered norm structure is both a constraint and a map. The Creation Guide occupies Layer 4 — the operational handbook — and above it stand administrative standards and the PMD Act. When the Guide's text offers no answer, the question moves upward to find one.
The goal of reading the Creation Guide is not to memorize its provisions. It is to understand what the Guide is implementing from Layers 1 through 3, so that when no provision exists, judgment can be grounded in the principles of those higher layers. That is what the foreword's mapping of the norm hierarchy is intended to make possible.