Recently, the General Office of the Shanghai Municipal Party Committee and the General Office of the Municipal Government jointly issued the "Implementation Opinions on Deepening the Reform of the Review and Approval System to Encourage Innovation in Drugs and Medical Devices" (hereinafter referred to as "32 Articles to Encourage Innovation in Drug Devices"), proposing to reform clinical trial management and speed up drug innovation. There are 32 reform tasks in six aspects, including the launch of medical devices, the establishment of a world-leading biomedical innovation and R&D highland, and the strengthening of drug and medical device life-cycle management and services.
The biomedicine industry is a strategic emerging industry that Shanghai focuses on developing. In recent years, the reform of Shanghai's drug and medical device review and approval system has achieved certain results: a batch of "global new" 1.1 new drugs that have not yet been marketed at home and abroad have been declared and marketed, and domestically advanced medical devices have greatly replaced imported products.
Despite the remarkable results of the previous reforms, the development of the biomedical industry in Shanghai is still facing challenges, and the deep-seated problems in the innovation of pharmaceuticals and medical devices have yet to be solved. The "32 Encouragement of Pharmaceutical and Device Innovation" aims at the bottleneck that hinders the development of Shanghai's pharmaceutical and medical device innovation and focuses on the "three enhancements": First, strengthen the reform and innovation of the review and approval system. Adopt to broaden the establishment of clinical trial institutions, reform the management and evaluation system of clinical trial institutions and medical staff participating in clinical trials, support the development of international multi-center clinical trials in Shanghai, recognize foreign clinical trial data, and accelerate the review and approval of pharmaceutical and medical devices. “One Netcom Office” has established and implemented measures such as a review mechanism that can be approved for listing with conditions to improve the efficiency of review, review and approval.
The second is to strengthen policy guidance and incentives. On the one hand, it encourages 32 innovations in pharmaceutical equipment to learn from each other and link up with policy documents such as "Shanghai 100 points for expanding opening up", "Shanghai 50 points for health services", "Biomedical Technology Innovation and Industrial Development Action Plan 2018-2020 (Draft for Solicitation of Comments)" and other policy documents; On the one hand, it is fully integrated with the current Shanghai biomedical industry equity investment funds, market-based insurance financial special subsidies, priority inclusion of innovative products in the medical insurance catalog and priority procurement of public hospitals, and other policies. It clarifies the implementation entities and the responsibilities of all parties, and strengthens the policies. Synergy.
The third is to strengthen supervision and services throughout the life cycle. To consolidate the experience of Shanghai's first reform pilot program in the country in the early stage. Implement the reform requirements of “decentralization, regulation and service”, strengthen supervision during and after the event, clarify that the listing license holder shall bear the legal responsibility of the whole life cycle, and the supervision department shall implement the whole process supervision; give full play to the national “Medical Device Innovation Shanghai Service Station” and “Shanghai” The role of the "Drug Evaluation and Verification Center" is to provide more precise policy support and full-process services for Shanghai pharmaceutical and medical device R&D and production enterprises.
