PMDA and MHLW: who issues what
The Pharmaceuticals and Medical Devices Agency (PMDA) carries out scientific review, GMP and QMS inspections, and safety monitoring for Japan. MHLW holds legal authority and issues most binding ordinances and notifications. In practice, many documents a US company finds on PMDA’s site are MHLW notifications reposted by PMDA, while others are PMDA’s own (consultation procedures, review points, Q&As).
That distinction matters twice: for legal weight, and for reuse terms, because the issuer’s policy applies.
Types of documents
| Document | Typical issuer | Use |
|---|---|---|
| Notifications on approval and review | MHLW, posted by PMDA | Procedures and expectations |
| Review guidelines and points to consider | PMDA or MHLW | Technical expectations for specific products |
| Q&As | MHLW or PMDA | Interpretation of new rules |
| Consultation guidance | PMDA | How to request PMDA consultations |
| Tentative English translations | PMDA | Orientation for foreign companies |
PMDA’s English site also provides tentative translations of selected regulations, such as the QMS ordinance chapters (PMDA). Its site notice warns that pages may be machine-translated and that PDF, Excel, Word and PowerPoint files are not translated.
PMDA’s website policy
PMDA’s English website policy states (PMDA):
- PMDA owns copyright in site content unless otherwise indicated, and the Public Data License 1.0 applies unless otherwise indicated.
- Users must cite the source; edited content must be labeled and must not suggest a public institution created it.
- Logos and mascot designs are excluded.
- Downloads should be limited to what is necessary; bulk, excessive or frequent downloads, automated crawling and download applications are not permitted.
The Japanese policy gives the same rules, with attribution in the form “Source: PMDA website (page URL)” (PMDA site policy, Japanese).
Why we rate this “check required”
PDL1.0 is a permissive default, but three things need checking per document:
- Separate rights notices on individual pages or files.
- Third-party content, such as industry association templates, academic figures or company data inside guidance.
- Issuer: if a document is an MHLW notification, MHLW’s terms also apply and the MHLW original should be tracked.
The crawling restriction is the most practical constraint for AI projects: build your collection deliberately and slowly, rather than scraping the site.
Using PMDA documents in AI and RAG
- Record issuer, document number and date for each document.
- Link reposted MHLW notifications to the MHLW original.
- Keep Japanese originals as the reference and tag English translations as tentative.
- Respect download limits and log what was collected and when.
- Generate PDL1.0 attribution for outputs.
Common mistakes
- Treating PMDA-hosted MHLW notifications as PMDA documents.
- Relying on machine-translated pages for requirements.
- Crawling the PMDA site to build a dataset.
- Ignoring third-party figures inside guidance PDFs.
Checklist
- Identify issuer for every document collected
- Check page-level rights notices
- Collect within PMDA’s download rules
- Keep Japanese originals and translation status
- Add attribution and edit notices to outputs
How AskDona helps
AskDona reads your submission documents and procedures against the PMDA and MHLW guidance you load and shows which expectations are addressed and where, with page citations. Run a sample PMDA requirements check on one guidance document. AskDona shows the evidence; your regulatory team decides.
Editor’s note: Website policy details come from PMDA’s English and Japanese policy pages read on the date below. Our “check required” rating is a first-pass judgment, not legal advice.
FAQ
Are PMDA documents free to reuse? Generally under PDL1.0 with attribution, unless a document says otherwise or contains third-party material.
Can I crawl the PMDA website? No. PMDA’s policy prohibits automated crawling and bulk downloads.
Are PMDA English translations official? Many are labeled tentative; use the Japanese originals as the reference.
What is the difference between PMDA and MHLW documents? MHLW issues most binding rules; PMDA reviews, inspects and publishes guidance, often reposting MHLW notifications.
References
All pages opened and checked by October 26, 2026.
| Source | Type | Used for |
|---|---|---|
| PMDA: Website policies (English) | Regulator policy | PDL1.0, crawling restriction |
| PMDA: Site policy (Japanese) | Regulator policy | Attribution format |
| PMDA: QMS ordinance translations | Regulator page | Tentative translations |