Key Updates In New Version Of China GMP Compared With Old Version


On March 22, 2022, NMPA published the updated version of China GMP (Good Manufacturing Practice) and GSP (Good Supply Practice). The new GMP and GSP will take effective since May 1st, 2022. BradyKnows QA team made assessment and summarized key updates in new version of China GMP compared with old version as below:

1.Fully implement the medical device registrant filing entity system, and strictly implement the main responsibility of the enterprise. The following impacts are mainly aimed at enterprises that entrust production.

2.Simplify relevant application materials and procedural requirements. The following impacts are mainly aimed at production enterprises.

3.Enrich and improve supervision means, improve operability, and solve practical problems in supervision.

4.Strengthen risk management and increase penalties for illegal acts.

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