Educational·6 topics total

Ad Regulations── The 6 frameworks governing pharmaceutical promotion in Japan, organized in one place.

Japan's pharmaceutical "what's allowed and what isn't" is not set by a single rule. Law, government notices, Q&A collections, industry self-regulation, practical manuals ── six documents with different roles, working in concert, constrain the whole. Start with the list. Each topic's explanation will be published on this page in turn.

Advertising regulation (Pharmaceutical Act §§66–68)

Prohibition of exaggerated advertising, restrictions on advertising for specific-disease drugs, prohibition of pre-approval advertising. The legal foundation underlying all promotional rules.

The Suspecting Eye — Reading Risk Beyond Regulation

Compliance is not zero risk. Systematizing the judgment to read what regulation cannot — the fear of misperception and the public eye — through 4 risk layers, 7 stakeholders, and 6 questions. The "eye" you should hold before reading the concrete regulatory texts of Vols. 03–07.

Pharmaceutical Advertising Appropriateness Standards

The operating rules for Pharmaceutical Act §66. Governs the ads themselves — print, web, TV CMs (most recent revision: 2017).

Sales-Information-Provision Activity Guideline ("HanteiG")

MHLW guideline that drew the boundary lines around MRs' information-provision activities (issued 2018 / effective 2019).

HanteiG Q&A Collections (1st – 4th editions)

Case collections where MHLW answers field-level "is this OK or not?" questions. Coverage expanded with each new edition.

JPMA Code of Practice

The industry self-regulatory standard defined by the Japan Pharmaceutical Manufacturers Association. Above the legal floor, it requires prevention of conflicts of interest and transparency.

Industry self-reg

JPMA Material-Creation Guide (the "Toranomaki")

A practical manual for producing materials. Following the actual three-part structure — I. Product Information Summary, II. Specialist-journal (print) advertising, III. Other materials — it organizes the concrete points to check, including the 18 items of the comprehensive summary and the discipline of data and figures.

Industry practice

Promotional Activity Monitoring Project — ten years of incident records

Japan's MHLW has published findings from this monitoring project every year since FY2016. Each fiscal year is organised here along four axes: the incidents, what characterised them, how the regulator read them, and what the regulator asked for. Not what the rules forbid — what actually happened.

— Each topic will be published on this page once it has passed verification —

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