Announcement on the Release of the "Self-Regulatory Standard on Quality Management for the Preparation of Immune Cell Products"
CMBA [2016] No. 035
To all relevant organizations:
To standardize the preparation of immune cell products in China, strengthen quality management, and promote industry self-regulation, our Association has organized leading enterprises and experts in the field with reference to the Good Manufacturing Practice for Drugs (GMP) and other relevant regulations and guidelines. After more than a year of discussion, the "Self-Regulatory Standard on Quality Management for the Preparation of Immune Cell Products" has been formulated. After broad consultation and further revisions and refinement, the "Self-Regulatory Standard on Quality Management for the Preparation of Immune 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 Immune Cell Products"
China Medicinal Biotech Association
10 October 2016
