Sichuan: Encourage The Innovation Of Pharmaceutical Medical Devices.
In order to further improve the efficiency and service level of drug medical device review and approval in Sichuan Province, and fully implement the main responsibility of the drug medical device life cycle, the Provincial Party Committee Office and the Provincial Government Office recently issued the “Encouragement on Deepening the Evaluation and Approval System Reform”. The Implementation Opinions on the Innovation of Pharmaceutical Medical Devices will promote the innovation and development of the pharmaceutical medical device industry and effectively protect the people's use of drugs and medical devices safely and effectively.
The "Opinions" pointed out that all localities and relevant departments should fully understand the necessity of deepening the reform of the examination and approval system and encouraging the innovation of pharmaceutical medical devices, attach great importance to the reform and innovation of drug medical device review and approval, and perform their duties according to law. The task is implemented, and every step from the laboratory to the hospital is well done. The "Opinions" put forward five tasks in Sichuan Province, namely, ensuring the safety and effectiveness of drug use for the masses, enhancing the research strength of pharmaceutical medical devices, improving the ability of review and examination and approval, stimulating the innovation vitality of pharmaceutical medical devices and enhancing the competitiveness of the industry, so that the pharmaceutical industry can be realized. The rapid development has moved toward the middle and high-end, and the multi-level and diversified health needs of the people have been continuously met.
The "Opinions" clarified a number of important tasks, and proposed to promote clinical trial management reform, increase the number of clinical trial institutions for drugs and medical devices, accelerate the construction of internationally advanced and domestic leading clinical trial institutions, and encourage clinical trial institutions to actively participate in international multi-centers. Clinical trials, docking international rules.
It is necessary to encourage the innovation of pharmaceutical medical devices, adhere to the innovative development ideas of self-made, innovative and imitation, implement the special review and approval system for innovative drugs, establish a provincial drug test data protection system, encourage and support the induction of tissue regeneration, 3D printing. Chemiluminescence, nuclear magnetic resonance, leading the development of biomedical materials, dental equipment and materials, in vitro diagnostic reagents and instruments, and large-scale imaging equipment industry.
The "Opinions" proposed to speed up the examination and approval of innovative medical device evaluation, establish a technical review system based on the review and inspection, and establish a special evaluation and approval channel for innovative medical devices, which was approved by the national and provincial drug regulatory authorities. Innovative medical devices and clinically urgently needed medical devices are given priority review and approval. It is necessary to improve the quality and efficacy of generic drugs, strengthen the research of generic drug technology, increase the research on the original auxiliary materials, prescriptions and processes of generic drugs, and realize the consistency of the quality and efficacy of generic drugs with the original research drugs. In addition, it is necessary to establish a full life cycle covering the generic drugs. Quality management and traceability systems, strengthen supervision and inspection during research and development, production, circulation and use, and strengthen adverse reaction monitoring and sampling inspection.
The "Opinions" require that, in order to implement the main responsibility of the holder of the listing permit, the holder of the listing license shall bear full legal responsibility for the research and development of pharmaceutical medical devices, clinical trials, manufacturing, sales and distribution, adverse reactions and reports of adverse events. It is necessary to improve the archives of medical medical equipment, establish archives of medical and medical equipment in the province, publicize the catalogue of medical devices for restricted and encouraged drugs, guide the order makers to apply in an orderly manner, and scientifically and rationally formulate research and development and reporting plans. It is necessary to improve the quality control system, establish a professional drug and medical device review team, strengthen the risk diagnosis and judgment of drug medical device quality and safety, and strictly review and approve high-risk drug medical device review. It is necessary to fully implement the responsibility for supervision and inspection, increase the intensity of flight inspections, and seriously investigate and deal with problems and hidden dangers in accordance with the law, and take timely risk control measures, publicly inspect and punish the results in a timely manner, and establish a mechanism for counterfeiting and traceability. The traceability of counterfeit drugs provides clues.
In order to promote the implementation of related work, the "Opinions" clarified a series of safeguard measures, emphasizing the need to strengthen departmental cooperation. Among them, the Provincial Food and Drug Administration should play a leading role, do a good job in the implementation of reform and innovation, and coordinate the implementation of tasks. It is necessary to strengthen capacity building, promote the implementation of the institutions, personnel and funds for drug medical device review and approval, enrich the technical review force, and at the same time accelerate the establishment of a first-class provincial medical device review and inspection institution, and actively strive to review the drug medical device review. Incorporate into the scope of government procurement services and provide standardized and efficient review services. (Sichuan Daily)