The 38th plenary session of the Standing Committee of the Shanghai Municipal People’s Congress was held on the afternoon of December 29. The meeting voted and adopted the provisions of Shanghai Pudong New Area on promoting the construction of Zhangjiang biomedical industry to a new high (hereinafter referred to as the provisions), creating a world-class business environment for the development of biomedical industry in Pudong New Area, and providing a strong legal guarantee for starting the brand of Zhangjiang biomedical industry innovation highland and striving to build a world-class biomedical industry cluster.
There are 34 articles in the regulations. In view of the pain points and blocking points that have affected industrial development for a long time, the regulations adjust, implement and fill in the gaps of existing laws and regulations from five aspects: improving the management system, promoting reform breakthrough, innovating service mechanism, promoting industrial integration and strengthening resource guarantee. The highlights and breakthroughs are summarized in the following two aspects, First, there are flexible powers at the national level. For example, biological products can be entrusted at multiple points in Shanghai, and Shanghai will formulate relevant management measures for the self-development and use of in vitro diagnostic reagents. The second is to solidify and improve the administrative power and legal system at the level of Shanghai, such as establishing a customs clearance facilitation mechanism for the import and export of articles for biomedical R & D and special articles, promoting the supply guarantee of experimental animals and the management of animal biosafety laboratories, etc. in addition, it also involves the guarantee of a number of resource elements for industrial development.
On the same day, the Standing Committee of Shanghai Municipal People’s Congress held a press conference on the promulgation of the regulations to introduce the relevant situation of the regulations. Liu Ping, deputy director of Shanghai Economic and Information Technology Commission, introduced at the press conference that in order to further promote the construction of Zhangjiang biomedical industry innovation highland in Pudong New Area and solve the bottleneck of development, Shanghai Economic and Information Technology Commission and Pudong New Area government took the lead in formulating the provisions of Shanghai Pudong new area on promoting the construction of Zhangjiang biomedical industry to a new height for Pudong New Area, The formulation process has the following three considerations:
First, based on the implementation of the relevant tasks of the opinions of the CPC Central Committee and the State Council on supporting the high-level reform and opening up of Pudong New Area and building a leading area for socialist modernization (hereinafter referred to as the opinions of the leading area), promote the reform measures to be tried first. On the one hand, we will resolutely implement the contents directly related to the biomedical industry in the opinions of the leading zone, such as the pilot application of self-developed in vitro diagnostic reagents and the bonded maintenance of “two ends out” high-end medical equipment. On the other hand, implement the matters related to the development and extension of the biomedical industry in the opinions of the leading area, such as establishing an international vocational qualification certificate recognition system, optimizing the access standards of industrial land and increasing the supply of mixed land.
Second, based on solidifying and learning from innovative practice, promote the legalization of practice mechanism. The institutionalization and legalization of innovative practices in Pudong New Area through legislation, such as the entry and exit of special goods and the customs clearance of biomedical R & D goods, is the solidification and improvement of the “white list” system of pilot biological special goods and R & D goods in Pudong New Area. Another example is to learn from the successful practices in Boao, Hainan, Guangdong, Hong Kong and Macao Dawan District, Beijing free trade zone and other places, import drugs and machinery for licensing, and establish human genetic resources management service institutions.
Third, based on the demands and pain points of industrial development, adapt and optimize the existing regulations. Grasp the development direction of Pudong’s high-level reform and opening up, and make modifications to existing laws and regulations according to the opinions of the leading area, such as supporting diversified investors to carry out R & D and industrialization of human cells and gene technology according to the requirements of promoting first try, proposing pilot multi-point entrustment and optimizing review and approval services according to the innovative management service mode, According to the sound factor market, put forward terms such as laboratory animal guarantee, talent incentive and guarantee, strengthening financial services, industrial land support, etc.
It is reported that this law is an industrial development promotion law issued under the background of the CPC Central Committee and the State Council supporting the high-level reform and opening up of Pudong New Area and building a leading area for socialist modernization. Since the legislative matters were determined at the end of July, Shanghai Municipal Economic and Information Technology Commission has jointly established a special legislative class in Pudong New Area, focusing on the practical needs of the whole industrial chain and life cycle of biomedicine, The formulation and promulgation of this law has been promoted in just five months after full discussion and repeated deliberation in the form of working meetings, enterprise symposiums and enterprise research.
(Shanghai Securities News · China Securities Network)
