14 November 2017 - Authored by:David Shen
The Chinese central government rolled out a 36-points reform plan for Chinese medicinal products and medical devices approval system on October 8.
Notably, China will adopt a US style patent linkage system including an automatic stay for patent challenge, start a pilot program for patent term extension and encourage patent challenges by generics. This will fundamentally change the economics of the pharmaceutical industry. Data exclusivity will be available to new medicines and the existing new medicine monitoring periods for locally manufactured new products may go away since it is redundant to the data exclusivity. At this point, some of time periods such length of automatic stay and patent term extension are still not finalised.
In addition, the China Food and Drug Administration (CFDA) will start to accept foreign clinical data for new drug applications if they meet the following requirements:
- The clinical trial data must meet Chinese requirements;
- Multi-center regional clinical trials (MRCT) will be encouraged;
- Chinese patients included in the trials are still likely required to account for ethnicity differences;
- As a result, CFDA will start to conduct overseas clinical trial inspection.
We believe the foregoing will dramatically transform the new drug approval process and speed up the new medicinal product approval in China. Overall, this should be a good news for companies that are planning to launch new medicinal products in China.
Please access here our free translation of an important Chinese central government policy announcement concerning the reform dated 8 October 2017.