Package inserts went digital in 2021
Japan’s 2019 PMD Act revision moved package inserts from paper to electronic publication. From August 1, 2021, inserts for medical devices and IVDs must be posted on PMDA’s information system, with paper inserts continuing only for products purchased directly by consumers (Emergo by UL). Prescription drugs followed the same digital model, with a barcode on the package linking to the current insert.
PMDA’s technical guide for businesses explains how a GTIN-14 package code links to the electronic insert through a redirect URL on the PMDA site, for example https://www.pmda.go.jp/PmdaSearch/bookSearch/01/{GTIN14} (PMDA guide, 3rd ed., June 11, 2021).
RMPs: what they contain
A Risk Management Plan (RMP) sets out a drug’s important identified risks, important potential risks and missing information, along with planned pharmacovigilance and risk-minimization activities. PMDA posts RMPs and related RMP materials for healthcare professionals and patients on its website, and its English page explains the system, though the documents themselves are Japanese (PMDA).
Who owns the copyright
This is the key difference from other Japanese regulatory sources. PMDA’s guide states that marketing authorization holders hold the copyright in electronic package inserts, RMPs and related materials. Outside use within the user’s own medical institution or pharmacy, copying, reprinting or distribution without the manufacturer’s permission is prohibited. App developers using the redirect URLs are asked to tell users about these rights, for example in their terms of use (PMDA guide).
PMDA’s general website policy (PDL1.0) therefore does not cover these documents’ content. In addition, PMDA prohibits bulk or automated downloading from its site (PMDA website policy).
What this means for AI and RAG
Our source list rates this row permission to be considered and advises checking separately for each step:
| Step | Question to answer |
|---|---|
| Copying | Are you storing full text, and under what permission? |
| Vectorization | Does creating embeddings count as reproduction under your agreement? |
| Answer generation | Will outputs quote or paraphrase the insert? |
| External distribution | Will users outside your organization see the content? |
Practical options:
- Use your own labeling. A company can usually use its own inserts and RMPs; confirm with the Japanese MAH if it is a partner.
- Link, don’t copy. Point users to the PMDA page for other companies’ inserts.
- License data. Where full-text access is needed, obtain permission from the rights holders or use a licensed database.
- Collect slowly and lawfully. Never crawl the PMDA site.
Common mistakes
- Assuming PMDA’s PDL1.0 policy covers package inserts.
- Building a competitor-label database by scraping PMDA.
- Ignoring that vectorization may need permission.
- Mixing old paper insert versions with current electronic ones.
Checklist
- Identify which inserts and RMPs you own
- Obtain permission for any third-party inserts you store
- Define permitted use for copying, embeddings, answers and distribution
- Respect PMDA’s download restrictions
- Track insert revision dates
How AskDona helps
AskDona checks your own Japanese labeling against your dossier, RMP and safety documents, flagging inconsistencies with page citations, without needing other companies’ content. Run a sample label-to-dossier consistency check on one product. AskDona shows the evidence; your regulatory team decides.
Editor’s note: Copyright statements come from PMDA’s guide for businesses (third edition, June 2021). Device digitization facts come from Emergo by UL; check PMDA for drug-specific rules. Not legal advice; our rating is a first-pass judgment.
FAQ
Who owns copyright in Japanese package inserts? The marketing authorization holders, according to PMDA.
Can I put package inserts from the PMDA site into an AI tool? Not without permission from the rights holder, except for your own products.
When did Japan move to electronic package inserts? August 1, 2021.
Are RMPs available in English? PMDA explains RMPs in English, but the RMPs themselves are in Japanese.
References
All pages opened and checked by October 26, 2026.
| Source | Type | Used for |
|---|---|---|
| PMDA: Guide on linking package codes to electronic inserts (3rd ed.) | Regulator guide | Copyright, redirect URLs |
| PMDA: RMP | Regulator page | RMP content |
| PMDA: Website policies | Regulator policy | Download restrictions |
| Emergo by UL: Package insert digitization | Consultancy news | Effective date for devices |