Tuesday, 4 October 2022 13.00 - 16.30 h
In May, the Chinese National Medical Products Administration (NMPA) published their new Annex 13 "GMP for Investigational Medicinal Products (IMPs)", which was incorporated into the Chinese GMP guidelines on July 01, 2022.
The working group that prepared the first draft of the Chinese "Annex 13 Investigational Medicinal Products (IMPs)" was already established in 2015. The first public consultation was held in late 2018 and the second consultation period started in early 2022. The published version now contains the following 14 chapters:
So far, the guideline is only available in Chinese language and can be checked on the NMPA website.