In 2015, the National Health and Family Planning Commission issued the Notice on Cancelling the Relevant Work on the Approval of the Clinical Application of the Third Class of Medical Technology (National Health (2015) No. 71), which canceled the point medical treatment including cellular immune technology. When the technology enters clinical application, it needs to obtain the original regulations for approval. The introduction of this policy has poured a cold water on the vigorous cellular immunotherapy.
The death of Wei Zexi in April this year set off a series of storms on the clinical application of medical technology, especially related to the clinical application of cellular immune technology. Some industry opinions suggest that the absence of government regulation is the most important cause of such incidents. However, the regulatory department's “one size fits all†call for cell therapy is far-reaching to the entire cell therapy industry. Perhaps the introduction of this policy will cause China to lose valuable opportunities for cornering in this area.
How to supervise the medical technology in China can get rid of the simple and rude, one tube will die, and the stage will be chaotic. In response to this problem, the Shanghai Round Table on the 17th Health Policy of “Medical Technology, How to Supervise†organized by the China-Europe Health Management and Policy Center and the Shanghai Food and Drug Safety Research Association was held at the Lujiazui International Finance Research Institute on September 3. At the meeting, relevant government departments, experts from medical institutions, relevant scholars and business representatives discussed the medical technology supervision from different angles.
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First of all, from the policy point of view, the Health Planning Commission is still the regulator of medical technology, and first clearly limits some medical technology can not enter clinical applications. Beyond the non-restrictive scope, the third category of medical technology requires clinical research before it enters clinical applications. Cellular immunotechnology is currently only available for clinical research and cannot be used in clinical applications. For the third type of medical technology, even if the clinical application is allowed, the medical institution needs to obtain the clinical application ability review, and the primary medical institution must not carry out the clinical application without authorization.
Cellular immune technology has attracted a lot of attention in this incident. The outbreak of the Wei Zexi incident has made this technology that has not yet been approved by clinical application questionable and urgently stopped. But in fact, CAR-T, TCR-T and PD-1/PDL-1 technologies are the hotspots of international immunotherapy. Qian Qijun, director of the Center for Cancer Biotherapy and Treatment of the Second Military Medical University, pointed out that the problems faced in cellular immunotherapy can be solved from two aspects. Firstly, the clinical application system of standardized tumor-specific T cells is established, and then it is safe, effective and easy to apply. Cell therapy technology.
In many countries, the Food and Drug Administration is usually responsible for the approval of access to medical technology clinical use, while China is the health administrative department. However, the health department may lack the resources and capabilities for supervision. Director Wang Yu of the Department of Affiliated Tumors of Fudan University also said that medicine is a highly specialized profession with high technical barriers, and the relevant knowledge of the supervisors is insufficient. Many factors have caused restrictions on the introduction and application of new technologies.
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