The Ministry of Health pointed out at a regular monthly work meeting yesterday that a one-year clinical research and application of stem cells will be carried out. The rectification regulations will stop all new project applications before July 1, 2012.

The Ministry of Health pointed out that in order to promote the scientific and orderly development of stem cell therapy technology and standardize stem cell therapy and clinical research behavior, the Ministry of Health and the State Food and Drug Administration decided to jointly carry out a one-year stem cell clinical research and application specification rectification work.

In the notice of rectification, the Ministry of Health and the Food and Drug Administration clearly stated that it is necessary to stop the activities of clinical research and application of stem cells that have not been approved by the Ministry of Health and the Food and Drug Administration. The conduct of self-development without any approval must stop immediately. For clinical trials of stem cell products that have been approved by the Food and Drug Administration, they must be strictly implemented in accordance with the quality specifications of the clinical trials of the approval documents and drugs, and clinical trial protocols cannot be arbitrarily changed, not to mention fees. At the same time, before July 1, 2012, all new project declarations will be stopped. At the end of the rectification or in the process of carrying out the rectification, relevant departments will be organized to notify the special rectification activities.

"The field of stem cell therapy is really messy," said a brokerage researcher. "Until now, the country has not approved any stem cell drugs. At present, stem cell treatments on the market are all illegal medical practices, and there are also many doctor-patient disputes. ”

Biophag’s chairman Zhang Fabao said that the Ministry of Health has three implications. First, it shows that the stem cell industry’s regulatory policies will be expected soon; Second, the country further clarified the regulation of the stem cell industry, which is under the jurisdiction of the State Food and Drug Administration; The industry will enter the elimination screening, survival of the fittest.

ST Zhongyuan Secretary Xia Liang said that he firmly believes that this measure launched by the Ministry of Health will play a positive role in regulating the long-term sound development of the industry.