China GMP and Registration for APIs - Live Online Training

China first introduced GMP in 1988, and since then the GMP regulations are revised and updated several times. Most of the existing GMP requirements and guidance documents were updated by the so called National Medical Products Administration (NMPA), China’s new Drug Regulatory Authority since 2018, and replace former guidelines published by the CFDA (China Food and Drug Administration). In 2021, the NMPA published a new guideline in regard on the inspection system and GMP certificates, which influenced the certification procedure tremendously.

Also in 2021, the NMPA issued new guidelines with information relevant for changes in registrations of drug products, for administrative and for technical processes. To keep track with the mandatory guidance documents of the regulatory authority as well as the understanding of the GMP requirements and registration procedures for APIs are the prerequisites to register APIs in China. 

This Live Online Training provides an overview of the regulatory and GMP requirements regarding APIs in China.