Japan GMP for Drugs and Quasi-drugs
Japan's GMP requirements, set out in MHLW Ministerial Ordinance No. 179 and administered by the PMDA and prefectural authorities under the Pharmaceuticals and Medical Devices (PMD) Act. A 2021 revision strengthened the pharmaceutical quality system, cross-contamination controls, and data integrity to align with ICH and PIC/S expectations.
Manufacturers supplying the Japanese market, including foreign manufacturers holding accreditation. Japan is a PIC/S participating authority, so expectations align closely with the PIC/S GMP Guide.
- 01Operate a pharmaceutical quality system aligned with ICH Q10
- 02Prevent cross-contamination with risk-based controls
- 03Maintain data integrity across manufacturing records
- 04Undergo GMP conformity assessment linked to marketing authorisation
The 2021 revision of Ordinance No. 179 strengthened PQS, cross-contamination, and data-integrity requirements toward ICH/PIC/S alignment.
MHLW Ordinance No. 179: frequently asked questions
Quick answers to common questions about MHLW Ordinance No. 179.
What is MHLW Ordinance No. 179?
MHLW Ordinance No. 179 — Japan GMP for Drugs and Quasi-drugs — is a regulation issued by the Pharmaceuticals and Medical Devices Agency (Japan). Japan's GMP requirements, set out in MHLW Ministerial Ordinance No. 179 and administered by the PMDA and prefectural authorities under the Pharmaceuticals and Medical Devices (PMD) Act. A 2021 revision strengthened the pharmaceutical quality system, cross-contamination controls, and data integrity to align with ICH and PIC/S expectations.
Who does MHLW Ordinance No. 179 apply to?
Manufacturers supplying the Japanese market, including foreign manufacturers holding accreditation. Japan is a PIC/S participating authority, so expectations align closely with the PIC/S GMP Guide.
What are the key requirements of MHLW Ordinance No. 179?
PMDA MHLW Ordinance No. 179 requires, among other things: Operate a pharmaceutical quality system aligned with ICH Q10; Prevent cross-contamination with risk-based controls; Maintain data integrity across manufacturing records; Undergo GMP conformity assessment linked to marketing authorisation.
When was MHLW Ordinance No. 179 last updated?
The current version of MHLW Ordinance No. 179 dates from August 2021. The 2021 revision of Ordinance No. 179 strengthened PQS, cross-contamination, and data-integrity requirements toward ICH/PIC/S alignment.
Live openFDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.
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When MHLW Ordinance No. 179 — or any GxP requirement — is revised, recalled against, or clarified by new guidance, the Weekly GxP Briefing surfaces it. Free, one email a week.