Three ordinances, three responsibilities
Japan splits pharmaceutical quality and safety duties across three MHLW ministerial ordinances:
| Ordinance | Applies to | Covers |
|---|---|---|
| GMP (Good Manufacturing Practice) | Manufacturing sites, including foreign sites accredited in Japan | Manufacturing control and quality control at the site |
| GQP (Good Quality Practice) | Marketing authorization holders (MAHs) | Quality assurance over products placed on the Japanese market, including oversight of manufacturers and market release |
| GVP (Good Vigilance Practice) | MAHs | Post-marketing safety management |
For a US manufacturer, GMP governs its own plant; GQP governs what its Japanese MAH (or its own Japanese subsidiary) must do to oversee it. Quality agreements between the two are where the ordinances meet.
The 2021 GMP revision
The revised GMP ministerial ordinance took effect on August 1, 2021, the same day as revisions to the PMD Act. A PMDA author’s review in the Journal of Health and Medical Science describes the main change as introducing a pharmaceutical quality system at manufacturing sites as a step toward international harmonization, alongside measures to prevent recurrence of quality problems that had led to recalls caused by serious GMP failures and organizational misconduct (Mishima, NIPH journal, 2022). The same PMD Act revision made a legal compliance system a duty for pharmaceutical companies.
For US firms used to ICH Q10 and EU GMP, the revised ordinance will feel familiar in concept. The difference is in the details of the accompanying notifications, which set out interpretation and expectations in Japanese.
What the 2025 PMD Act amendment adds
The 2025 amendment (Act No. 37 of 2025, enacted May 14, 2025) makes Quality Assurance Managers and Safety Control Managers legal requirements and lets the Minister order changes to responsible officers, with these provisions taking effect by May 2027 (Nishimura & Asahi). It also adds supply-control managers and shortage reporting, and by May 2028 a new medium-risk change category with a three-month decision. Expect GQP and related notifications to be updated to reflect these roles.
Working with the notifications
Most practical detail sits in MHLW notifications issued by the Pharmaceutical Safety Bureau and its divisions: interpretation of each GMP article, Q&As, and inspection procedures. When building a knowledge base, our source list recommends keeping:
- Notification number (for example, Yakuseiyaku-hatsu numbers)
- Issue and effective dates
- Amendment history and links to superseded versions
Without these, an AI tool cannot tell a user which interpretation applied at the time of an inspection.
Reuse terms
MHLW content is generally usable under the Public Data License 1.0 unless a page states otherwise (MHLW). PDL1.0 allows copying, translation, modification and commercial use, requires source citation, requires a statement when content has been edited, and excludes logos and content under separate terms; third-party rights inside documents remain the user’s responsibility (Digital Agency).
Using GMP, GQP and GVP texts in AI and RAG
- Tag by ordinance so GMP site duties are not confused with GQP MAH duties.
- Chunk by article and keep the matching notification interpretation linked.
- Store effective dates, including August 1, 2021 for the GMP revision and 2027 and 2028 dates for the 2025 amendment.
- Translate with care and label translations as edited content under PDL1.0.
- Do not mix in PIC/S or EU text as if it were Japanese law; keep them as comparison sources.
Common mistakes
- Writing a quality agreement that covers GMP but not the MAH’s GQP obligations.
- Using pre-2021 interpretations of the GMP ordinance.
- Ignoring notification Q&As because they are “only guidance”.
- Losing track of which notification was superseded.
Checklist
- Map GMP, GQP and GVP duties between your site and the Japanese MAH
- Confirm procedures reflect the August 2021 GMP revision
- Plan for 2027 Quality Assurance Manager requirements
- Keep notification numbers and dates in your knowledge base
- Apply PDL1.0 attribution and edit notices
How AskDona helps
AskDona reads your site SOPs and quality agreements against the Japanese GMP and GQP requirements you load, showing where each article is covered and where it is not, with page citations. Run a sample Japan GMP procedure check on one SOP. AskDona shows the evidence; your quality team decides.
Editor’s note: Details of the 2021 GMP revision are summarized from a Japanese journal review; consult the ordinance and notifications for exact requirements. Licensing notes are not legal advice. Our “conditional use” rating is a first-pass judgment.
FAQ
What is the difference between GMP and GQP in Japan? GMP applies to manufacturing sites; GQP applies to marketing authorization holders’ quality oversight.
When did Japan’s revised GMP ordinance take effect? August 1, 2021.
Does the 2025 PMD Act amendment affect quality roles? Yes. Quality Assurance Managers and Safety Control Managers become legal requirements by May 2027.
Can MHLW GMP notifications be reused? Generally yes under PDL1.0 with attribution and edit notices, subject to exceptions.
References
All pages opened and checked by October 26, 2026.
| Source | Type | Used for |
|---|---|---|
| NIPH: Points of the revised GMP ordinance (Mishima, 2022) | Journal review | 2021 revision |
| Nishimura & Asahi: 2025 PMD Act amendments | Law firm newsletter | Quality governance changes |
| MHLW: Copyright policy | Regulator policy | PDL1.0 |
| Digital Agency: Public Data License 1.0 | Government license | Reuse terms |