Announcement on the release of the “Self-regulatory Specifications for Quality Management of Stem Cell Preparation Preparation”
Zhongsheng Xiezi [2016] No. 039
Relevant units:
In order to standardize the preparation of stem cell preparations in my country, strengthen quality management, and promote industry self-discipline, our association has organized key enterprises and experts in the industry since April 2015 to refer to the Good Manufacturing Practice (GMP), the Guiding Principles for Quality Control and Preclinical Research of Stem Cell Preparations (Trial), and the Management Measures for Stem Cell Clinical Research (Trial). After more than a year of discussion, the Self-Discipline Standard for Quality Management of Stem Cell Preparation was formulated. After extensive solicitation of opinions and further revision and improvement, the “Self-Discipline Standards for Quality Management of Stem Cell Preparation Preparation” is now released and will come into effect on the date of release.
Attachment: Self-regulatory specifications for quality management of stem cell preparations
China Medical and Biotechnology Association
October 25, 2016