Japan GQP — Quality Management for Marketing Authorisation Holders
The Ministerial Order on the Standard of Quality Management for Pharmaceuticals, Quasi-Pharmaceuticals, Cosmetics, and Regenerative Medicine Products — **MHLW Order No. 136 of 2004**, universally called GQP. It is the companion instrument to the GMP ordinance and the one non-Japanese manufacturers routinely overlook: GMP (Order No. 179) binds the manufacturing site, while GQP binds the **marketing licence holder** in Japan and governs the written agreement with each manufacturer, periodic audit, change notification, and the batch certification without which product cannot be released to the Japanese market.
Always verify against the current published text before relying on it for a submission or inspection.
Scope & applicability
Marketing licence holders of pharmaceuticals, quasi-pharmaceuticals, cosmetics and regenerative medicine products in Japan. It does not bind the manufacturing site directly — it binds the party that places the product on the market, which is why a foreign manufacturer must appoint a Japanese marketing authorisation holder and then satisfy that holder’s GQP obligations contractually.
Quick reference · What GQP puts on the marketing licence holder
GQP is the half of Japanese quality regulation that foreign manufacturers miss: these duties belong to the marketing licence holder in Japan, and no amount of GMP compliance at the factory discharges them.
- A written agreement with each manufacturer — Art. 7 requires an agreement covering the scope of manufacturing activities, manufacturing and quality control, and site release procedures
- Technical requirements in that agreement — Production processes and testing/analytical methods must be specified, not assumed
- Periodic audit rights — The licence holder must audit whether manufacturing and quality control are suitably and timely conducted
- Transport and hand-over quality control — Methods for controlling quality during transport and hand-over of product
- Advance notice of quality-relevant change — The manufacturer must notify proposed changes to processes or test methods before implementing them, through a named responsible person
- Prompt notice of adverse information — Discontinuation, recall, disposal or other public-health measures — and other quality information — must be reported promptly to the licence holder
- Batch-by-batch market release certification — Art. 9 forbids releasing product to market before certification; a qualified person in the quality assurance department certifies each batch and records the shipping destinations
GMP governs the site; GQP governs the market release. A batch can be GMP-compliant and still be unreleasable in Japan.
Source: MHLW Order No. 136 of 2004, Chapter 2 arts. 7 and 9 — PMDA tentative translation updated 1 July 2024. Verify against the current text before relying on it for a submission.
Key requirements
- Conclude a written agreement with each manufacturer covering the seven matters listed in Article 7, and record it in the quality-management operational procedures
- Audit each manufacturer periodically for suitable and timely manufacturing and quality control
- Require advance notification of any change to production processes or test methods that may affect quality, through a named responsible person
- Certify each batch for market release or rejection through qualified quality-assurance personnel, and document the certification and the shipping destinations (Art. 9)
- Never release product to market before that certification has been suitably conducted
Implementation tips
- Treat the Article 7 agreement as a regulatory deliverable, not a commercial quality agreement — its seven required subjects are enumerated in the ordinance and an auditor will read them against it
- Map your existing EU-style Qualified Person release against GQP Article 9: the functions rhyme, but the Japanese certification duty sits on the marketing licence holder’s quality assurance department, not on the manufacturing site
- Where the certifier is someone other than the quality assurance manager, build the written reporting route Article 9(4) requires before an inspection asks for it
Revision notes
Order No. 136 was made in 2004 alongside the GMP ordinance as part of the same restructuring of Japanese pharmaceutical quality regulation. PMDA published a refreshed tentative English translation, issued as an excerpt covering the pharmaceutical chapter, on 1 July 2024.
Where this control fails
live FDA enforcementLive FDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
MHLW Ordinance No. 136: frequently asked questions
Quick answers to common questions about MHLW Ordinance No. 136.
What is MHLW Ordinance No. 136?
MHLW Ordinance No. 136 — Japan GQP — Quality Management for Marketing Authorisation Holders — is a regulation issued by the Ministry of Health, Labour and Welfare (Japan). The Ministerial Order on the Standard of Quality Management for Pharmaceuticals, Quasi-Pharmaceuticals, Cosmetics, and Regenerative Medicine Products — **MHLW Order No. 136 of 2004**, universally called GQP. It is the companion instrument to the GMP ordinance and the one non-Japanese manufacturers routinely overlook: GMP (Order No. 179) binds the manufacturing site, while GQP binds the **marketing licence holder** in Japan and governs the written agreement with each manufacturer, periodic audit, change notification, and the batch certification without which product cannot be released to the Japanese market.
Who does MHLW Ordinance No. 136 apply to?
Marketing licence holders of pharmaceuticals, quasi-pharmaceuticals, cosmetics and regenerative medicine products in Japan. It does not bind the manufacturing site directly — it binds the party that places the product on the market, which is why a foreign manufacturer must appoint a Japanese marketing authorisation holder and then satisfy that holder’s GQP obligations contractually.
What are the key requirements of MHLW Ordinance No. 136?
MHLW Ordinance No. 136 requires, among other things: Conclude a written agreement with each manufacturer covering the seven matters listed in Article 7, and record it in the quality-management operational procedures; Audit each manufacturer periodically for suitable and timely manufacturing and quality control; Require advance notification of any change to production processes or test methods that may affect quality, through a named responsible person; Certify each batch for market release or rejection through qualified quality-assurance personnel, and document the certification and the shipping destinations (Art. 9).
When was MHLW Ordinance No. 136 last updated?
The current version of MHLW Ordinance No. 136 dates from January 2004. Order No. 136 was made in 2004 alongside the GMP ordinance as part of the same restructuring of Japanese pharmaceutical quality regulation. PMDA published a refreshed tentative English translation, issued as an excerpt covering the pharmaceutical chapter, on 1 July 2024.
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Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.