Heavy! Encourage 32 innovations in pharmaceutical machinery, accelerate the launch of new products

Medical Network November 8th, November 7th, the General Office of the Shanghai Municipal Committee, the General Office of the Municipal Government issued the "Implementation Opinions on Deepening the Reform of the Examination and Approval System to Encourage the Innovation of Pharmaceutical Medical Devices" (hereinafter referred to as 'Encouraging Drugs and Innovations 32') .

Focusing on the two national strategies of building China (Shanghai) Pilot Free Trade Zone and the globally influential Science and Technology Innovation Center, benchmarking the highest international standards, the best level, promoting the development of international leading biomedical industry clusters, promoting pharmaceuticals medical instruments The quality has reached the international advanced level, and the drug medical equipment supply guarantee system and the post-event supervision system that are compatible with the excellent global cities have been established, so that the public can use them, and can afford new medicines and advanced medical equipment.

Strive to make the number of clinical trial institutions in the city reach more than 80, to achieve full coverage of clinical specialties, and the quality management level has reached international advanced;

Strive to gather more than 20 internationally influential biomedical innovation research and development institutions;

Strive to register more than 30 independent innovative pharmaceutical medical device products with core technological advantages every year;

To achieve 'Internet +' smart supervision covering the entire life cycle of pharmaceutical medical devices;

Implement 'One Netcom Office' and change the 'On-road run approval' to the whole process online;

Strengthen the life cycle management and service of drugs and medical devices

Shanghai has always used finance and ports as its two pillars. The '32 articles' are now released, including the '50 articles' issued in July. Does this continuous policy mean that Shanghai will meet in the future? health As a pillar industry?

The policy interpretation released on the same day pointed out that the background of the 'Encourage Drugs and Innovations 32' is as follows: The bio-pharmaceutical industry is a strategic emerging industry with key development in Shanghai.

In recent years, the reform of the drug and medical device review and approval system in Shanghai has achieved certain results. It has taken the lead in launching a pilot system for listing license holders, promoting the evaluation of generic drug consistency, and accelerating the reform of drug clinical trials. The 'global new' class 1 new drugs have been listed on the market, and domestic advanced medical devices have largely replaced imported products.

However, the development of the biomedical industry is facing challenges, such as the lack of a leader. enterprise There are a large number of outflows of innovation, insufficient investment in research and development, etc. Some deep-seated problems in supporting innovation of pharmaceutical medical devices have yet to be resolved. For example, clinical trial resources are abundant but not fully released. There are many R&D institutions but insufficient support policies, and the people use new drugs. The urgent need for medicine has yet to be met.

Therefore, 'Encourage 32 innovations in pharmaceutical machinery' to consider the problems and advantages of Shanghai, and propose support with Shanghai characteristics. drug Policy measures for the development of medical device innovation, reforming the drug and medical device review and approval system, stimulating the vitality of innovation in enterprises and institutions, and boosting Shanghai biology medicine Industrial innovation capability maintains a leading position in the country.