Stem cell technology is at the core of cell therapy. Regenerative medicine, with stem cell therapy at its heart, has shown potential therapeutic effects on a range of degenerative and chronic diseases.
As one of the core therapeutic approaches of the new medical revolution, stem cell technology is expected to become a third new pathway for treating disease, after pharmacotherapy and surgery. It has broad application prospects and enormous social demand.
With its 1.3 billion people, China possesses extremely abundant stem cell resources as well as huge market demand. In basic research, China still lags behind the United States and Japan, but in many areas of translational research China is in a leading position. China fully has the conditions, capability and opportunity to lead the world in stem cell technology, clinical translation and drug development.
However, beneath the enormous potential of China's stem cell industry, problems such as the absence of industry standards, relatively lagging laws and regulations and insufficient industrial policy support are also significant, and seriously constrain the healthy development of the stem cell industry.
Given that China has huge market space and potential, and that this is a major innovative technology in the medical field, the country should adhere to independent innovation, hold on to core technologies and reduce – or even avoid – overseas introduction of biomedical-resource-related technologies.
Furthermore, China's stem cell industry currently still maintains an internationally advanced level. At this critical juncture for the industry, China urgently needs to accelerate the improvement of relevant policies, advance the conversion of stem cell scientific and technological achievements, and seize the initiative in the international competitive landscape of the stem cell industry.
Encouragingly, over the past year the country has rolled out a series of policies in the stem cell field.
In early 2015, the Ministry of Science and Technology issued the "Implementation Plan for the National Key R&D Program – Key Special Project on Stem Cells and Translational Medicine (Draft for Comment)". In November, the first batch of 2016 project application guidelines for the pilot special projects of the National Key R&D Program was officially released, launching the pilot work of the "Stem Cells and Translational Medicine" key special project and strengthening investment and deployment in stem cell basic and translational research.
In August 2015, China issued two major regulatory documents governing stem cell clinical research: the "Administrative Measures for Stem Cell Clinical Research (Trial)" and the "Guiding Principles for Quality Control and Preclinical Research of Stem Cell Preparations (Trial)".
In December 2015, the National Health and Family Planning Commission launched the filing of stem cell clinical research institutions, ushering in a new industry era of regulating the qualifications and operating conditions of stem cell clinical research institutions, regulating the conduct of stem cell clinical research, safeguarding subjects' rights and interests and promoting the healthy development of stem cell research.
The rollout of these policies signals that the stem cell industry is finally beginning to enter the market. Yet, given the dynamic nature of stem cell technology and its products, the complexity of extraction and preparation, and the multidisciplinary nature of transplantation – making them arguably the most complex therapeutic products in the history of medicine – this poses challenges for our scientific and management personnel that are higher than ever before.
To address this, beyond the unremitting efforts of scientific and technical workers, what is needed even more is unified deployment at the national level, with product technology as the orientation, strengthening strategic planning and implementation, creating a sound industry environment, and forming a fair, just, well-allocated, IP-respecting and progressive environment, popularizing scientific awareness across society and guiding the highly efficient combination of capital and technology – so as to rapidly and efficiently put the standardization of the stem cell technology industry into practice.
To this end, two recommendations are put forward:
1. Establish rules and adopt classified, tiered management.
Treat the various components of the stem cell industry differently, with different policies, regulations and administrative approval regimes. For upstream and midstream segments that do not directly involve public health – such as stem cell banks and non-clinical stem cell products – administrative approval should be entirely abolished and the market allowed to play its role in survival of the fittest. For midstream and downstream segments directly related to public health – such as stem cell drugs and stem cell clinical treatment – the government should lead in formulating industry standards, and drug regulators should rigorously control safety and efficacy through technical standards.
2. Unify technical standards and encourage well-regulated clinical trials.
As long as stem cells and related products can be produced under GTP/GMP conditions in a standardized manner and to unified standards, R&D enterprises should be permitted and encouraged to register and apply for clinical trials in accordance with drug standards, advancing the marketization process. Only when a substantial number of effective stem cell drugs are approved for marketing can the cost of stem cell therapy genuinely be reduced and a true stem cell industry truly come about.
