The people's government of pudong new area shall establish a mechanism to promote the development of biomedical industry in pudong new area, strengthen the development of biomedical industry led by zhangjiang, promote the innovative development of biomedical industry in pudong new area.
The relevant town people's government of Pudong New Area, street offices, park management organizations should do a good job in their areas of responsibility to promote the development of the biomedical industry to ensure the work. Article 5 The municipal economy and information technology department is responsible for coordinating the development of the city's biomedical industry, and coordinating the promotion of Pudong New Area biomedical industry innovation highland construction.
City and Pudong New Area development and reform, science and technology, business, health, drug supervision, medical security, finance, planning and resources, ecological environment, human resources and social security, local financial supervision, greening and amenities departments and customs and other units in accordance with their respective responsibilities and the provisions of this article, is responsible for the promotion of the biomedical industry in Pudong New Area. Article 6 The People's Government of Pudong New Area shall establish the Expert Committee for the Development of Biomedical Industry in Pudong New Area. The expert committee is responsible for the development of biomedical industry in Pudong New Area, project planning, key layout and other matters to carry out scientific evidence, put forward opinions and recommendations. The expert committee's opinions and recommendations as an important reference for decision-making on the development of biomedical industry. Article 7 The people's governments of the city and Pudong New Area shall promote the development of human cells and gene industry into the biomedical industry development coordination and promotion mechanism, under the premise of risk-controllable, to support qualified diversified investment subject to carry out research and development of human cells, gene technology and promote the industrialization process.
City and Pudong New Area science and technology, health and other departments shall strengthen the Pudong New Area biomedical enterprises to carry out human cells, gene technology development and application of supervision, strengthen risk control. Article 8 For Pudong New Area biomedical enterprises within the scope permitted by the relevant state departments, to explore the implementation of bonded supervision of the goods (including materials, consumables, reagents, etc.) required to carry out cross-border research and development.
In accordance with the requirements of the supervisory department information **** enjoyment, risk control, Pudong New Area, the relevant key biomedical enterprises can be carried out in accordance with national regulations, high value-added, high technology content, in line with the environmental requirements of the bonded maintenance of medical equipment; Pudong New Area, the relevant enterprises within a specific area can be carried out in accordance with national regulations, the export of high-end medical equipment back to the country for repair. The repaired medical devices shall be reshipped abroad according to their sources. Article IX Pudong New Area, with commercial-scale production of drugs and meet the conditions of drug production quality management standards of biopharmaceutical companies, drug clinical trials phase of the application for drug production license, in the commitment to clinical samples of the production conditions and the application for marketing authorization phase of the production conditions are consistent with the case of the municipal drug regulatory authorities can issue the "Drug Manufacturing License". Article 10 The holder of the Pudong New Area drug marketing license may produce drugs on its own, or may entrust the production of drug manufacturers in accordance with the law. Approved by the state drug regulatory authorities, Pudong New Area, the holder of a listed drug license can be entrusted to the city within the scope of more than one qualified drug production enterprises. The city's drug regulatory authorities should provide guidance and services, and cooperate with the state drug regulatory authorities to carry out the relevant review work.
Blood products, narcotic drugs, psychotropic drugs, toxic drugs for medical use, and drug-type chemicals shall not be entrusted with the production, except as otherwise provided by the state drug regulatory authorities. Article XI of the same variety of domestic products are not yet on the market in vitro diagnostic reagents, Pudong New Area eligible medical institutions in accordance with clinical needs, can be developed on their own, under the guidance of a licensed physician in the use of the unit. Specific measures developed by the municipal drug regulatory department in conjunction with the municipal health department. Article 12 The municipal people's government, within the scope of national authorization, may approve the Pudong New Area qualified medical institutions to import a small amount of clinically urgent need of drugs and medical devices. The imported drugs and medical devices shall be used for specific medical purposes in the designated medical institutions.
Encourage qualified biomedical enterprises to carry out clinical real-world data application research on a small number of drugs and medical devices imported for clinical urgency, explore the use of clinical real-world data for the registration of drugs and medical devices, and promote the accelerated listing of drugs and medical devices. Article 13 The city, in accordance with the relevant state authorization, in the relevant areas to promote the pilot qualified Pudong New Area drugs and medical devices trading platform to carry out cross-border e-commerce retail import of some drugs and medical devices business.
The city drug regulatory authorities shall combine the actual needs of the development of the biomedical industry in Pudong New Area, in order to ensure that the quality of the operation of the premise of safety and control, optimize the implementation of wholesale drug licensing to meet the demand for modern logistics of drugs.