Center for Drug Evaluation (CDE) Issued the Notification of “Technical Guideline for the Pharmaceutical Study and Evaluation of Ex-vivo Genetic Modification System (Interim)” (No. 29, 2022)

In order to standardize and guide the pharmaceutical research of in vitro gene modification systems, under the deployment of the National Drug Administration, the Drug Evaluation Center organized the formulation of the "Technical Guidelines for Pharmaceutical Research and Evaluation of In Vitro Gene Modification Systems (Trial)" (see attachment).

According to the requirements of the "Notice of the General Office of the National Drug Administration on Issuing the Procedure for the Release of Drug Technical Guidelines" (Drug Supervision General Drug Administration [2020] No. 9), after review and approval by the National Drug 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 Vitro Gene Modification Systems (Trial)

National Drug Administration Drug Evaluation Center

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 Vitro Genetically Modified Systems (Trial)" (No. 29, 2022)