Source: Drug Testing Center, State Food and Drug Administration

CDE publishes Technical Guidelines for Non-Clinical Studies of Human Stem Cell Products

In order to regulate and guide the non-clinical research and evaluation of human stem cell products, under the deployment of the State Drug Administration, the Center for Drug Approval has formulated the Technical Guidelines for non-clinical Research of human stem Cell Products (see annex). In accordance with the requirements of the Notice of the General Department of the State Drug Administration on the Release procedure of the Technical Guidelines for Printing and Distributing Drugs (Comprehensive Drug Administration of the State Drug Administration (2020) No. 9), it is hereby issued with the approval of the State Drug Administration and shall come into force as of the date of promulgation.

Annex: Technical Guidelines for non-clinical studies of human stem cell products

CDE

  January 12, 2024