CFDA expected to approve stem cell application
NHFPC and CFDA organized "Ninth Stem Cell Clinical Research Meeting of Committee" in late december. The expert panel reached a basic consensus on stem cell research in the field of regulatory policy. The official document is expected to approve recently, if everything goes well. It consists of three parts: "Management Regulation on Stem Cell Clinical Trials", "Management Regulation on Stem Cell Research Base of Clinical Trials", "Guideline on Stem Cell Preparation Quality Control and Preclinical Study". The Laws & Regulations regulate Stem cell clinical trials, preparation and research base of clinical trials systematically.
The absence of supervision system seriously hindered the development of stem-cell industry. China has not standardized cell quality test and established the department to accept quality test. The administrative examination, approval and supervision rules of Stem cell research and clinical application has not formed. Moreover, some companies make unscientific commercial speculation.
The market value of stem-cell industry will run to several hundred billion by 2016.Stem cell technology has obtained a remarkable therapeutic efficacy in clinical practice, and the indications of stem cell mainly include hematological diseases, diabetic foot, hepatopathy, parkinson's disease, osteoarticular injury, burn and so on. With good clinical effect and large-scale indications, stem-cell treatment is regarded to have a bright future in the biomedical field, although most of the mechanisms on stem cell technology have not be explored.
"Stem-cell industry has three Business model, Each has its advantages.” said Professor Zhong Hua from Chinese academy of medical sciences, "Upstream of the industry chain is to collect and store stem cell; midstream is to develop stem cell technology and downstream is to transplant stem cell for therapy."
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