Stem cell technology is the core of cell therapy technology. Regenerative medicine with stem cell therapy as the core has shown potential therapeutic effects on a variety of degenerative diseases and chronic diseases.
As one of the core treatments in the new medical revolution, stem cell technology is expected to become the third new way to treat diseases after drug treatment and surgical treatment, with broad application prospects and huge social demand.
China has a population of 1.3 billion, extremely rich stem cell resources, and also has huge market demand. In terms of basic research, although China still lags behind the United States and Japan, in terms of translational application research, China is in a leading position in many aspects. It has the conditions, capabilities and opportunities to lead the world trend in the fields of stem cell technology, clinical transformation and drug research and development.
However, despite the huge potential for the development of my country’s stem cell industry, problems such as a lack of industry standards, relatively lagging laws and regulations, and insufficient support from industrial policies also exist, which seriously restrict the healthy development of the stem cell industry.
Since my country has huge market space and potential, as a major innovative technology in the medical field, the country should adhere to independent innovation, insist on mastering core technologies, and reduce or even avoid the introduction of foreign technologies related to biomedical resources.
Furthermore, China’s current stem cell industry is still at an internationally advanced level. In this critical period for the development of the industry, my country urgently needs to speed up the improvement of relevant policies, promote the transformation of stem cell scientific and technological achievements, and seize the opportunity in the international stem cell industry competition.
It is gratifying that in the past year, the country has introduced a series of policies in the field of stem cells.
In early 2015, the Ministry of Science and Technology issued the “Implementation Plan for the National Key R&D Program on Stem Cells and Translational Medicine (Draft for Comments)”. In November, the first batch of project application guidelines for the National Key R&D Program Pilot Project in 2016 was officially announced, launching the key special pilot project on “Stem Cells and Translational Medicine” to strengthen investment and layout in the basics and transformation of stem cells.
In August 2015, my country’s two major normative documents for the management of stem cell clinical research, the “Measures for the Management of Stem Cell Clinical Research (Trial)” and the “Guiding Principles for Quality Control and Preclinical Research of Stem Cell Preparations (Trial)” were released.
In December 2015, the National Health and Family Planning Commission launched the registration process for stem cell clinical research institutions, beginning a new era in the industry that standardizes the institutional qualifications and conditions for stem cell clinical research, standardizes stem cell clinical research behavior, protects the rights and interests of subjects, and promotes the healthy development of stem cell research.
The introduction of a series of policies is a signal that the stem cell industry has finally begun to market. However, due to the dynamic nature of stem cell technology and its products, the complexity of extraction and preparation technology, and the comprehensiveness of transplantation technology, it can be called the most complex therapeutic product in the history of human medicine, posing higher challenges to our scientific and technical personnel and managers than before.
In this regard, in addition to the unremitting efforts of scientific and technological workers, it is also necessary to have unified deployment at the national level, product technology-oriented, strengthen strategic planning and implementation, create an excellent industrial environment, form a fair and just, reasonable distribution, respect for intellectual property rights, and positive environment, popularize scientific understanding of society, guide the efficient combination of capital and technology, so as to quickly and efficiently implement the standardization of the stem cell technology industry.
To this end, two suggestions are made:
1. Formulate rules and manage by classification and level.
Treat each component of the stem cell industry differently and provide different policies, regulations and administrative approval systems. For the upstream and midstream parts of the industry that do not directly involve public health, such as stem cell banks and non-clinical stem cell products, administrative approvals will be completely cancelled, allowing the market to play the role of survival of the fittest; for the midstream and downstream parts of the industry that are directly related to public health, such as stem cell drugs and stem cell clinical treatments, the government will take the lead in formulating industry standards, and the drug regulatory department will strictly control their safety and effectiveness through technical standards;
2. Unify technical standards and encourage standardized clinical trials.
As long as stem cells and related products can be standardized under GTP/GMP conditions and can be produced according to unified standards, R&D companies should be allowed and encouraged to register and apply for clinical trials in accordance with drug standards to promote their marketization process. Only when a large number of effective stem cell drugs are approved for marketing can the cost of stem cell treatment be truly reduced and the stem cell industry be truly realized.