The Ministry of Health is the regulatory health authority responsible for developing laws, regulations, and policies for cellular therapies in China. In 2009 the Ministry of Health classified cellular therapies as category three medical technologies. This category of medical technologies is considered to have the highest risk, pose ethical issues, and has not yet been scientifically proven for its therapeutic value. As such, before a cellular therapy product may be used, approval from a technical audit board is required. Other products and therapies classified as category three medical technologies include gene therapies, surgical treatments for mental disorders or drug addiction, and sex changes. While the regulations governing the use of cellular therapies is still maturing, China has proposed draft guidelines and standards to help shape the future development of these therapies.
China is in the process of developing appropriate regulations and guidance documents to regulate the clinical translation of stem cell research and strengthen stem cell clinical trial management. In 2012, the Ministry of Health stopped accepting new applications for clinical trials of stem cell products as part of a year-long development program to establish regulations for the cellular therapy industry. In 2013, the Ministry of Health and the China Food and Drug Administration (SFDA) jointly publicized the draft rules to obtain comments on the proposed regulations governing stem cell clinical trial management. The draft rules focused on factors to help assure the safety of patients such as requiring clinical trials to be subject to ethical review, requiring researchers to submit relevant product-related materials that contribute to the safety of the products, and would only allow SFDA-certified hospitals to participate in cellular therapy clinical trials. The draft rules also disallowed charging patients for experiemental cellular therapy treatments.
Links to relevant regulatory authorities’ websites are accessible in the Related Information box.