Hainan | China's first "Administrative Measures for Access, Clinical Research, and Translational Application of Stem Cell Medical Technologies in the Pilot Zone (Trial)" will be officially issued soon!
来源:Stem Cell Home
2019-07-31
Recently, the official website of the Hainan Provincial Health Commission published "Reply from the Hainan Provincial Health Commission to Proposal No. 0391 of the Second Session of the Seventh Committee of the Hainan Provincial Committee of the Chinese People's Political Consultative Conference (Response Category: B)." The reply clearly states that, in the area of cutting-edge medical technology research, to standardize and promote clinical research and translational applications of biomedical frontier technologies in the pilot zone, the Provincial Health Commission has drafted the "Provisional Measures for the Access, Clinical Research, and Translational Application Management of Stem Cell Medical Technologies in the Pilot Zone," which will be officially issued soon.
According to a recent report from the Hainan Daily, Hainan Province has formulated the "Administrative Measures for Access to Stem Cell Medical Technologies and Their Clinical Research and Translational Applications in the Boao Lecheng Pilot Zone," as well as the "Project Proposal for the Construction of Hainan Province's Base for the Transfer and Commercialization of Innovatively Developed New Drug Achievements." These initiatives aim to pioneer and test cutting-edge approaches in stem cell and new drug translation within the Boao Lecheng International Medical Tourism Pilot Zone.
Stem cells are a population of cells with the remarkable ability to self-renew, proliferate extensively, and differentiate into multiple cell types—often referred to as "seed cells." Under specific conditions, these "seed cells" can further specialize into various tissue-specific cells, playing a crucial role in cell replacement and tissue regeneration. Clinical applications based on stem cells are widely regarded as holding immense promise, potentially offering solutions to currently intractable and incurable diseases that have long baffled medical science.
In fact, the Boao Lecheng Pilot Zone initially included plans for stem-cell therapy from its very inception. On February 28, 2013, the State Council officially approved Hainan's establishment of the Boao Lecheng International Medical Tourism Pilot Zone. According to the "State Council's Approval on Agreeing to Establish the Boao Lecheng International Medical Tourism Pilot Zone in Hainan" (Document No. [2013] 33), the pilot zone would receive nine supportive policies—later famously known as the "National Nine Measures." Notably, the second policy allows the pilot zone to apply for and conduct cutting-edge medical research projects, such as clinical studies involving stem cells, based on its own technical capabilities.
Currently, the country has expanded this support policy to allow all free trade zones nationwide to undertake cutting-edge clinical research projects in stem cell technology!
To further elevate the development of the free trade pilot zones, the State Council recently issued the "Notice on Several Measures to Support Deepening Reform and Innovation in Free Trade Pilot Zones" (hereafter referred to as the "Several Measures"). The measures explicitly state that medical institutions within the pilot zones may, based on their technical capabilities and in accordance with relevant regulations, undertake cutting-edge clinical research projects involving stem cell technologies (responsible department: National Health Commission).
The implementation of this measure once again underscores the Chinese government's strong commitment to advancing stem cell therapy technology. It also signals that China's stem cell industry is poised for rapid growth, thanks to robust national policy support. Stem cell technology will play a pivotal role in bolstering China's Healthy China initiative and significantly enhancing the nation's overall public health standards.
Relevant content is excerpted as follows:
Currently, stem cells are already being widely used in therapeutic research for a variety of diseases, including diabetes, leukemia, stroke, Parkinson’s disease, spinal cord injuries, hematological disorders, neurological conditions, limb ischemia, cardiovascular and cerebrovascular diseases, endocrine system disorders, surgical conditions, skin diseases, cancers, and immune system-related illnesses. As stem cell therapy technology continues to advance, these versatile cells hold the potential to play a transformative role in treating nearly every human disease—opening up new possibilities for curing many of today’s previously untreatable conditions. At the heart of this innovation lies regenerative medicine, which is poised to emerge as a groundbreaking third approach to disease treatment—joining drug therapies and surgical interventions—and is rapidly becoming a focal point of the next medical revolution.
Stem cell technology has been attracting significant attention both internationally and domestically. In China, stem cells have already been included in the country’s "13th Five-Year Plan for the Development of National Strategic Emerging Industries" as well as the "Healthy China 2030" Outline. The favorable policy direction from the national government has created a robust environmental foundation for industry growth, while the frequent introduction of supportive policies has sent positive signals and played a crucial role in driving the sector forward.
China is at an internationally advanced level in the field of stem cell research. With the nation’s growing support for the stem cell industry and the continuous refinement of regulatory policies, the future prospects for China’s stem cell sector are truly limitless.
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