Good Manufacturing Practice for Drugs (China)
China's GMP for drugs (2010 Revision), administered by the NMPA under the Drug Administration Law. Structured similarly to EU GMP with a main text and appendices (e.g. sterile products), it raised Chinese GMP substantially toward international norms.
Drug manufacturers supplying the Chinese market. Appendices cover sterile drugs, APIs, biological products, and traditional Chinese medicine.
- 01Operate a compliant pharmaceutical quality system
- 02Apply the relevant product appendix (e.g. sterile)
- 03Maintain validation and data integrity
The 2010 Revision (effective 2011) substantially upgraded China GMP; the 2019 Drug Administration Law introduced the MAH system.
China GMP (2010 Revision): frequently asked questions
Quick answers to common questions about China GMP (2010 Revision).
What is China GMP (2010 Revision)?
China GMP (2010 Revision) — Good Manufacturing Practice for Drugs (China) — is a regulation issued by the National Medical Products Administration (China). China's GMP for drugs (2010 Revision), administered by the NMPA under the Drug Administration Law. Structured similarly to EU GMP with a main text and appendices (e.g. sterile products), it raised Chinese GMP substantially toward international norms.
Who does China GMP (2010 Revision) apply to?
Drug manufacturers supplying the Chinese market. Appendices cover sterile drugs, APIs, biological products, and traditional Chinese medicine.
What are the key requirements of China GMP (2010 Revision)?
NMPA China GMP (2010 Revision) requires, among other things: Operate a compliant pharmaceutical quality system; Apply the relevant product appendix (e.g. sterile); Maintain validation and data integrity.
When was China GMP (2010 Revision) last updated?
The current version of China GMP (2010 Revision) dates from March 2011. The 2010 Revision (effective 2011) substantially upgraded China GMP; the 2019 Drug Administration Law introduced the MAH system.
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.
Track the standards that move
When China GMP (2010 Revision) — or any GxP requirement — is revised, recalled against, or clarified by new guidance, the Weekly GxP Briefing surfaces it. Free, one email a week.