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.
What this does not cover
stated in the document's own scope- It does not set manufacturing-site requirements; those are in the GMP ordinance.
- It does not govern post-marketing safety management, which is the GVP ordinance; GQP hands safety-related quality information to the safety management department.
- The original text excluded active pharmaceutical ingredients from “drugs” for its purposes.
- Medical devices, in the 2004 text, are now covered by separate quality management rules.
Always verify against the current published text before relying on it for a submission or inspection.
Overview
The GQP ordinance — Ministerial Ordinance No. 136 of 2004 — sets the quality assurance standards that a Japanese marketing authorisation holder must meet. Its central idea is that the authorisation holder, not only the manufacturer, carries the duty to assure product quality on the market: controlling market release, supervising manufacturers including foreign manufacturers, handling quality information and defects, handling recalls, and other duties needed to control product quality. It sits alongside the GMP ordinance, which governs manufacturing sites, and the GVP ordinance on post-marketing safety.
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.
Legal basis & how it acquires force
A ministerial ordinance of the Ministry of Health, Labour and Welfare, issued on 22 September 2004 under the then Pharmaceutical Affairs Law, which required the standards to be set by ministerial ordinance. Compliance is a condition of holding a marketing licence. The ordinance has since been amended and renamed; the current text covers drugs, quasi-drugs, cosmetics and regenerative medicine products, with medical devices now under separate quality management rules. MHLW published a tentative English translation of the original text in 2005.
Document structure
| Part | Covers |
|---|---|
| Chapter 1 — General Provisions | Purpose and the definition of quality assurance duty |
| Chapter 2 — Drugs | Organisation and personnel, including the quality assurance department and quality assurance manager; procedure documents; contracts with manufacturers; market release; manufacturing and quality control oversight; quality information; recall; self-inspection; training; storage; records |
| Chapter 3 — Quasi-drugs and cosmetics | Proportionate quality assurance standards for these product classes |
| Original Chapter 4 — Medical devices | Device quality assurance in the 2004 text, since moved to separate rules |
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.
International alignment
Japan has been a PIC/S participating authority since July 2014, and its GMP ordinance applies the manufacturing-site requirements. GQP covers what EU law places largely on the qualified person and the marketing authorisation holder: release to the market and supervision of manufacturers. In the original text, the release decision could be made by a designated person in the quality assurance department or, under a contract, at the manufacturer, with deviations reported to the quality assurance manager.
MHLW Ordinance No. 136: frequently asked questions
Quick answers to common questions about MHLW Ordinance No. 136.
Who must comply with GQP?
The marketing authorisation holder. It must establish a quality assurance department, appoint a quality assurance manager, write procedure documents, contract with its manufacturers, control market release and supervise the manufacturers’ manufacturing and quality control.
What experience must the quality assurance manager have?
In the original text, at least three years in quality assurance or similar duties, the competence to perform them, and responsibility for the quality assurance department.
How long must GQP records be kept?
In the original text, five years for most drugs, or one year beyond shelf life where that is longer; ten years beyond shelf life for biological-origin products and cell or tissue-based drugs; thirty years beyond shelf life for specified biological-origin and human-blood-origin products; and five years for training records.
Can the manufacturer make the market release decision?
Yes, under a prior contract that sets the procedure, designates a person at the site, requires deviations to be reported to the quality assurance manager, and lets the authorisation holder periodically verify the release duties.
This standard in practice
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.