China GMP: New Annex 13 for IMPs

Recommendation

28-30 March 2023

Global Registration and Life Cycle Management of APIs - Live Online Training
Contents of the regulatory information in the ASMF and CEP

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:

• Chapter 1 Scope
• Chapter 2 Principles
• Chapter 3 Quality Management
• Chapter 4 Personnel
• Chapter 5 Plants, Facilities and Equipment
• Chapter 6 Management of Materials
• Chapter 7 Documentation
• Chapter 8 Preparation Management
• Chapter 9 Quality Control
• Chapter 10 Batch Release
• Chapter 11 Shipment
• Chapter 12 Complaints and Recalls
• Chapter 13 Recovery and Destruction
• Chapter 14 Glossary

So far, the guideline is only available in Chinese language and can be checked on the NMPA website.