China Stem Cell Regulations - A Quick Digest

Online, November 26, 2010 (Newswire.com) - The Ministry of Health of P.R.China introduced new regulations governing the clinical use of stem cells in China. We were very excited about the new regulations since Dr. Yihua An, MD, PhD, was invited by the Ministry of Health to participate in the Advisory Committee to frame the new law.

Dr.Yihua An is the Director of the Department of Stem Cell Transplantation at Wujing General Hospital of Chinese People's Armed Police Forces.

China stem cell regulations came under skepticism in the international media mainly due to lack of accurate information.

Below we provide a quick digest of the laws regulating new biotechnologies including stem cell treatments in China which came into force from 1 May 2009.

The general provision of the law is to promote the development of medical science and technology, to improve the quality and safety of stem cell care. Medical technology should follow the standardized scientific and ethical principles for providing safe, effective care.

According to the new regulations medical institutions that provide stem cell therapy should be suited to its designated function, possess professional qualifications, expertise and operational capacity.

Employees of such a facility should have a minimum of three years of experience in a senior or technical position in medical and health institutions, universities or research institutions. The facility should be equipped appropriately with quality control system in†place.

Medical institutions applying for clinical application of stem cell treatments should first pass a technical audition. As part of the audition the related authorities check if the institution has conducted appropriate clinical trials, safety and efficacy are proven. Additionally they also require approval from the appropriate administrative department, clearance from the medical ethics review committee.

In order to apply for approval, medical institutions should submit a feasibility study report, including:
The basic profiles of medical technology, including domestic and international applications, indications, contradictions, side effects, technical line, quality control measures, efficacy of standards, assessment, treatment and other medical technology with the risks , efficacy, cost and treatment comparison.

Main technical personnel's qualification, relevant curriculum vitae, medical equipment, facilities and other auxiliary conditions, risk assessment and contingency plans.Clearance from the medical ethics review body.
Violation of the law is punishable according to formerly existing acts and laws.

"A lot of thought and debate has gone into framing these regulations for the emerging biotechnologies like stem cell therapy and gene therapy. Through out the process we were focused on bringing a fine balance between science, biotech industry and most importantly patient care. I hope the new regulations for stem cell treatments in China will promote safe and effective treatments for all", said Dr. An.

The regulation is published in full length at the website of the Ministry of Health of P.R.China
http://www.moh.gov.cn/publicfiles/business/htmlfiles/mohyzs/s3585/200903/39511.htm