Health and Family Planning Commission: the first normative document for clinical research of stem cells in China will be issued soon

Source: after caixin.com's clinical application of stem cells on December 23, 2014 was stopped several years ago, China's relevant policies tend to be cautious But according to Caixin, a new normative policy is in the works The national health and Family Planning Commission and the State Food and Drug Administration recently held a meeting of stem cell clinical research expert committee The opinions formed in the meeting are being reported level by level, waiting for the final issuance According to a person from the national health and Family Planning Commission told Caixin, as a result, the regulatory policy for the research and development of new stem cell projects has gained basic consensus If nothing unexpected, the official document is expected to be passed in the near future, and its main purpose is to promote the progress of stem cell research in China People from the national health and Family Planning Commission told Caixin that the stem cell industry, as a cutting-edge biotechnology, has been sought after by the capital market and favored by pharmaceutical enterprises The health and Family Planning Commission also intends to formulate corresponding industrial policies to promote technological development At the same time, the State Food and drug administration has been worried about undertaking the task of stem cell drug review, and the progress of policy promotion is slow At present, under the leadership of the State Council and the personal consultation of relevant senior leaders, the health and Family Planning Commission and the State Food and drug administration have reached an agreement These people said that this system can fill the gap in the supervision of domestic stem cell industry, clinical regulations will pave the way for the development of domestic stem cell industry, and the approval of stem cell drugs will be accelerated The research and development base selects stem cells from the third grade a hospital as a kind of cell with infinite proliferation and differentiation potential, with the function of regenerating various tissues and organs Stem cells are widely distributed in early embryo, placenta and its appendages, bone marrow, peripheral blood and adult tissues According to the "12th Five Year Plan" of the national major scientific research plan for stem cell research, stem cells and their differentiated products provide a new way to effectively repair the damage of important tissues and organs of the human body and cure important diseases such as cardiovascular diseases, metabolic diseases, nervous system diseases, blood system diseases and autoimmune diseases Regenerative medicine with stem cell therapy as the core will become another way of disease treatment after drug treatment and surgical treatment On October 24, 2011, the Ministry of Health issued the notice on strengthening the management of cord blood hematopoietic stem cells, which requires that multiple measures be taken to strengthen the supervision of cord blood hematopoietic stem cell collection and application On January 6, 2012, the Ministry of Health issued the notice on carrying out clinical research on stem cells and application self-examination and self correction, which will stop using any unapproved stem cells in treatment and clinical trials before July 1, and stop accepting new stem cell project applications China's stem cell research has become cautious Han Zhongchao, director of the national stem cell engineering technology research center, told Caixin that the development of stem cell research in China once presented a more chaotic situation Stem cells were publicized as omnipotent by individual organizations, so as to expand the illegal commercial interests More and more medical institutions also carried out stem cell project research without knowing and declaring, which led to regulators' concern Stop it all According to Caixin, up to now, in addition to hematopoietic stem cell therapy for blood diseases, there has not been any medical institution's stem cell therapy accepted or reviewed by regulatory authorities The hospitals that carry out clinical application of stem cells belong to experimental clinical research According to the national health and Family Planning Commission, the new deal on stem cells is likely to stipulate that stem cell clinical trials and research must be carried out in the stem cell clinical research base, which should be selected from the class III class A hospitals of the drug clinical trial institutions recognized by the State Food and Drug Administration The approval of stem cell drugs is expected to speed up the treatment of stem cells, which is popular among many institutions According to the market research data provided by visiongain, the global market share of stem cell therapy in 2011 reached US $2.7 billion, mainly composed of bone marrow stem cell transplantation (BMT) At the same time, stem cell banks and supporting products have a market share of US $2.6 billion It is estimated that by 2016, the market share will reach 8.8 billion US dollars (the compound annual growth rate from 2011 to 2016 is 10.6%) Up to now, eight kinds of stem cell drugs or technologies have been approved for marketing and applied in clinical practice Indications include acute myocardial infarction, inherited or acquired hematopoietic system disease, spinal cord and bone injury, involving many countries such as the United States, South Korea, Canada, but China is not listed "We must be aware that in drug research and development, it is difficult for Chinese drugs with independent intellectual property rights to be approved and listed by FDA in Europe and the United States, and only stem cells have the hope to lead the world." Han Zhongchao said that China now ranks second in the whole field of stem cell research, and first in the field of bone marrow, umbilical cord and placenta stem cell research "The US clinical trial website is also the most registered in China, but due to the uncertainty of Chinese policies and regulations, there is no drug approval in China, so we are very anxious." At present, the upstream of China's stem cell industry chain is mainly stem cell collection and storage business, the midstream is stem cell technology research and development, and the downstream is stem cell transplantation and treatment "The upstream of stem cells, that is, the collection and storage business, is very mature in technology, and has a good development in the midstream and downstream We hope that the policy can have an opening to approve new drugs as soon as possible." Han Zhongchao said that the national stem cell product review center should be set up as soon as possible, with sufficient professionals, so as to make the review of cell products more flexible, scientific and transparent standards and management regulations, and further improve the development and regulatory system of stem cell technology and its application in China