Center for Drug Evaluation (CDE) Issued the Notification of “Technical Guideline for the Pharmaceutical Study and Evaluation of In-vivo Gene Therapy Products (Interim)” (No. 31, 2022)

In order to standardize and guide the pharmaceutical research and development, production and registration of in vivo gene therapy products, under the deployment of the National Medical Products Administration, the Drug Evaluation Center organized the formulation of the "Technical Guidelines for Pharmaceutical Research and Evaluation of In Vivo Gene Therapy Products (Trial)" (see attachment).

According to the requirements of the "Notice of the General Office of the National Medical Products Administration on Issuing the Procedure for the Release of Pharmaceutical Technical Guidelines" (Yaojianzongyaoguan [2020] No. 9), after review and approval by the National Medical Products Administration, it is now issued and will be implemented from the date of issuance.

This is hereby announced.

Attachment: Technical Guidelines for Pharmaceutical Research and Evaluation of In Vivo Gene Therapy Products (Trial)

National Medical Products Administration Drug Evaluation Center

May 26, 2022

Specific news link: Notice of the Center for Drug Evaluation of the National Medical Products Administration on the release of the "Technical Guidelines for Pharmaceutical Research and Evaluation of In Vivo Gene Therapy Products (Trial)" (No. 31, 2022)