The People's Government of Pudong New Area should establish a working mechanism to promote the development of biomedical industry in Pudong New Area, strengthen the development of biomedical industry led by Zhangjiang, and promote the innovative development of biomedical industry in Pudong New Area.
The people's governments of relevant towns, sub-district offices and park management institutions in Pudong New Area shall do a good job in promoting and ensuring the development of biomedical industry within their duties. Article 5 The municipal administrative department of economic informatization shall be responsible for coordinating the development of the biomedical industry in this Municipality, and coordinating and promoting the construction of an innovative highland of biomedical industry in Pudong New Area.
Municipal and Pudong New Area development and reform, science and technology, commerce, health, drug administration, medical security, finance, planning resources, ecological environment, human resources and social security, local financial supervision, greening the city and other departments and customs and other units shall be responsible for the promotion of the biomedical industry in Pudong New Area in accordance with their respective responsibilities and these Provisions. Article 6 The People's Government of Pudong New Area shall set up an expert committee for the development of biomedical industry in Pudong New Area. The expert committee is responsible for scientific demonstration of the development, project planning and key layout of the biomedical industry in Pudong New Area, and puts forward opinions and suggestions. The opinions and suggestions of the expert committee serve as an important reference for the development and decision-making of biomedical industry. Article 7 The Municipal People's Government and the Pudong New Area People's Government shall incorporate the promotion of human cell and gene industry into the coordinated promotion mechanism for the development of biomedical industry, support qualified diversified investors to carry out research and development of human cell and gene technology under the premise of controllable risks, and promote the industrialization process.
Municipal and Pudong New Area science and technology, health and other departments should strengthen supervision over the development and application of human cells and genetic technology by biomedical enterprises in Pudong New Area and strengthen risk management and control. Article 8 Explore bonded supervision of goods (including materials, consumables, reagents, etc.) for biopharmaceutical enterprises in Pudong New Area within the scope permitted by relevant state departments. ) need them to cross-border r&d. ..
According to the requirements of information sharing and risk control of regulatory authorities, relevant key biomedical enterprises in Pudong New Area can carry out bonded maintenance business of medical devices with high added value, high technology content and environmental protection requirements in accordance with state regulations; Relevant enterprises in a specific area of Pudong New Area can carry out the return and maintenance of exported high-end medical equipment according to state regulations. Medical devices after maintenance should be shipped abroad according to their sources. Article 9 If Pudong New Area has the conditions for commercial-scale production of drugs and meets the requirements of good manufacturing practice biopharmaceutical enterprises, and applies for a Drug Production License in the clinical trial stage of drugs, and the promised clinical sample production conditions are consistent with the stage of applying for marketing license, the municipal drug supervision and administration department may issue a Drug Production License. Article 10 The holder of the drug listing license in Pudong New Area may produce drugs by himself or entrust a drug production enterprise to produce drugs according to law. With the approval of the state drug supervision and administration department, the holder of the drug listing license in Pudong New Area may entrust more than one qualified drug production enterprise within the city to produce. The municipal drug regulatory department shall provide guidance and services, and cooperate with the national drug regulatory department to carry out relevant review work.
Blood products, narcotic drugs, psychotropic drugs, toxic drugs for medical use, and pharmaceutical precursor chemicals may not be commissioned for production, except as otherwise provided by the state drug supervision and administration department. Article 11 For in vitro diagnostic reagents that have not been marketed in China, qualified medical institutions in Pudong New Area can independently develop and use them in their own units according to clinical needs and under the guidance of medical practitioners. The specific measures shall be formulated by the municipal drug supervision department in conjunction with the municipal health department. Article 12 The Municipal People's Government may, within the scope authorized by the state, approve qualified medical institutions in Pudong New Area to import a small amount of medicines and medical devices urgently needed in clinic. Imported drugs and medical devices should be used for specific medical purposes in designated medical institutions.
Encourage qualified biomedical enterprises to carry out clinical real data application research on a small number of drugs and medical devices urgently needed for clinical import, explore the application of clinical real data in the registration of drugs and medical devices, and promote the accelerated listing of drugs and medical devices. Thirteenth according to the relevant authorization of the state, this Municipality has piloted and promoted the qualified drug and medical device trading platform in Pudong New Area, and carried out some retail imports of drugs and medical devices in cross-border electronic commerce.
The municipal drug supervision department shall, in combination with the actual needs of the development of biomedical industry in Pudong New Area, optimize the implementation of drug wholesale business license under the premise of ensuring the safety and controllability of business quality, so as to meet the needs of modern drug logistics.