Announcement on the Release of the "Self-Regulatory Standard on Quality Management for the Preparation of Stem Cell Products"
CMBA [2016] No. 039
To all relevant organizations:
To standardize the preparation of stem cell products in China, strengthen quality management, and promote industry self-regulation, since April 2015 our Association has organized leading enterprises and experts in the field to draw on the Good Manufacturing Practice for Drugs (GMP), the Guidelines for Quality Control and Preclinical Research of Stem Cell Products (Trial), the Administrative Measures for Stem Cell Clinical Research (Trial), and other documents. After more than a year of discussion, the "Self-Regulatory Standard on Quality Management for the Preparation of Stem Cell Products" has been formulated. After broad consultation and further revisions and refinement, the "Self-Regulatory Standard on Quality Management for the Preparation of Stem Cell Products" is hereby released and shall take effect from the date of release.
Attachment: Self-Regulatory Standard on Quality Management for the Preparation of Stem Cell Products
China Medicinal Biotech Association
25 October 2016
