Release date: 2014-12-29
After the clinical application of stem cells was stopped a few years ago, China's relevant policies have become cautious. However, according to Caixin reporter, a new normative policy is brewing.
The National Health and Safety Commission and the State Food and Drug Administration recently held a meeting of the Expert Committee on Stem Cell Clinical Research. The opinions formed by the meeting are being reported step by step, waiting for the final signing. According to a person from the National Health Planning Commission, Caixin reporters revealed that the new stem cell project research and development regulatory policy has reached a basic consensus. If no accidents, official documents are expected to be adopted in the near future, the main purpose of which is to promote the progress of China's stem cell research. .
The National Health and Family Planning Commission told Caixin that the stem cell industry, as a cutting-edge biotechnology, has always been favored by the capital market and favored by pharmaceutical companies. The Health 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 concerned about the task of undertaking stem cell drug review, and the progress of policy promotion is slow. At present, under the leadership of the State Council and the relevant senior leaders personally questioned, the Health Planning Commission and the State Food and Drug Administration reached an agreement.
The above-mentioned person said that this system can fill the gap in the domestic stem cell industry supervision, and the clinical regulations will pave the way for the development of the domestic stem cell industry, and the approval of stem cell drugs will also accelerate.
R&D base selected from top three hospitals
Stem cells are cells with unlimited proliferation and differentiation potential and have the function of regenerating various tissues and organs. Stem cells are widely found in early embryos, placenta and their appendages, bone marrow, peripheral blood, and adult tissues.
The "12th Five-Year Plan" of the National Major Scientific Research Program for Stem Cell Research states that stem cells and their differentiated products are effective in repairing important tissues and organs of the human body and curing cardiovascular diseases, metabolic diseases, nervous system diseases, blood system diseases, Important diseases such as autoimmune diseases provide new avenues. Regenerative medicine with stem cell therapy as its core will become another treatment route for medical 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", and adopted various measures to strengthen supervision on the collection and application of cord blood hematopoietic stem cells. On January 6, 2012, the Ministry of Health issued the "Notice on Conducting Stem Cell Clinical Research and Applying Self-examination and Self-correction Work", and will stop testing any unapproved use in treatment and clinical trials before July 1. Stem cells and stop accepting new stem cell project applications. China's stem cell research has become more cautious.
Han Zhongchao, director of the National Stem Cell Engineering Technology Research Center, told Caixin reporter that the development of stem cell research in China was once more chaotic, and stem cells were advertised as omnipotent by individual organizations, thereby expanding illegal commercial interests. More and more medical institutions are also The stem cell project research was carried out without knowing or undeclared, which led the regulator to stop it.
According to Caixin reporter, China's stem cell research has been developed so far, except for hematopoietic stem cells for the treatment of blood diseases, stem cell treatment of any medical institution has not been accepted or reviewed by the regulatory authorities. The hospitals that carry out clinical application of stem cells are all experimental clinical studies.
According to the National Health and Family Planning Commission, the stem cell new policy is likely to stipulate that stem cell clinical trial research must be carried out at the stem cell clinical research base. The research base needs to be a tertiary hospital from the drug clinical trial institution that has been identified by the State Food and Drug Administration. Selected in the middle.
Stem cell drug approval is expected to speed up
Stem cell therapy is highly sought after and is favored by many institutions. According to market research data provided by Visiongain, the global market share of stem cell therapy in 2011 reached 2.7 billion US dollars, and the market is mainly composed of bone marrow stem cell transplantation (BMT). At the same time, the market share of stem cell banks and ancillary products reached $2.6 billion. It is estimated that by 2016, the market share will reach 8.8 billion US dollars (2011-2016 compound annual growth rate of 10.6%).
Up to now, there have been 8 kinds of stem cell drugs or technologies approved for clinical use in the world. The indications include acute myocardial infarction, hereditary or acquired hematopoietic diseases, spinal cord and bone injury, etc., involving the United States, South Korea, Canada, etc. Many countries, but China is not listed.
"We must be soberly aware that in terms of drug research and development, drugs with independent intellectual property rights in China are difficult to be approved and listed in the US and FDA. Only stem cells hope to reach the forefront of the world." Han Zhongchao said that China is now The entire stem cell research field is ranked second, ranking first in bone marrow, umbilical cord, and placental stem cell research. "The US clinical trial website is also the most registered in China, but due to China's unclear policies and regulations, China has not approved drugs, we are very anxious."
At present, the upstream of China's stem cell industry chain is mainly the collection and storage of stem cells, the midstream is the development of stem cell technology, and the downstream is stem cell transplantation and treatment.
"The stem cell upstream, that is, the collection and storage business, is very mature in technology, and it has also developed very well in the middle and downstream. We hope that the policy can have an opening and approve new drugs as soon as possible." Han Zhongchao said that the national stem cell product review should be established as soon as possible. The evaluation center is equipped with sufficient professionals to make the evaluation of cell products more flexible, and the standards and management regulations are scientific and transparent, and further improve the development and supervision system of stem cell technology and its application in China.
Source: Caixin Net
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