How the industry has adapted to changes in China CMC regulatory

Broadcast date

Thu, Dec 1, 2022

 

Presented by

    Mei Cai - Abbvie

 

Quick Description

China is an immense commercial market, in a full transition phase – moving from a national regulatory environment and market to a more harmonized regulatory landscape. There are, however, still Chinese-specific requirements that need to be fulfilled when entering the Chinese market.

Details

In June 2022, the team produced a poster to stimulate conversations between the industry and the NMPA for the purpose of aligning on the most efficient way to manage registrations and post approval changes.

In this presentation, we aim to share how the industry has adapted to these changes and provide an overview of the main benefits and challenges encountered to date with suggested enhancements. This has been possible by working closely with RDPAC. Streamlining data requirements by increasing alignment for regulators and industry.

Speakers

Mei Cai

Ph.D

Abbvie