Notification on the Public Solicitation of Implementation Suggestions and a Chinese Version for the ICH S12 Guideline: Considerations for Non-Clinical Biologics Distribution of Gene Therapy Products

To promote the smooth implementation of the newly revised ICH guidelines in China, the Center for Drug Evaluation under the National Medical Products Administration has drafted the Implementation Suggestions for ICH S12 Guideline: Considerations for Non-Clinical Biologics Distribution of Gene Therapy Products. The center is now soliciting public opinions on the S12 implementation suggestions for a period of one month.

If you have any modification suggestions, please provide feedback to the following email address: gkzhqyj@cde.org.cn.