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Recently, Shanghai issued "Several Policies and Measures for Shanghai to Accelerate the Construction of a Global Biomedical R&D Economy and Industrialization Highland" to support the development of Shanghai's biomedical R&D economy and put forward a number of policies and measures to accelerate the construction of a global biomedical R&D economy and
industrialization highland.
Main objectives
The main goal of Shanghai's policy measures is that by 2025, the development pattern of Shanghai's global biomedical R&D economy and industrialization highland will initially take shape, the overall scale of R&D economy will reach more than 100 billion yuan, and more than 100 innovative drugs and medical devices will be cultivated or introduced Heavy products, cultivate more than 50 innovative headquarters with compound functions such as biomedical R&D, sales and settlement, cultivate more than 20 high-level biomedical incubators and accelerators, promote the listing and trading of more than 1,000 biomedical patents in Shanghai, add more than 5 biomedical municipal engineering research centers, and provide innovative services
such as engineering verification and transformation for more than 100 early high-quality achievements of universities and research institutes 。
By 2030, Shanghai's status as a global biomedical R&D economy and industrialization highland will be further highlighted, the overall scale of R&D economy will be further improved, a number of innovative drugs and medical device blockbuster products developed and listed in Shanghai will emerge, and a number of biomedical innovative headquarters and innovation platforms with domestic and foreign influence will be gathered, and the R&D economy will become an important supporting force
for the development of the city's biomedical industry 。
Among them, in the process of supporting the listing and use of innovative products in the research and development, Shanghai will further improve the speed of review and approval of innovative products, accelerate the admission and use of innovative products, and improve the recommendation mechanism for the inclusion of innovative drugs and devices in commercial medical insurance, as follows:
Further improve the speed of innovative product review and approval
For Class II medical devices with significant clinical value and strong innovation, after meeting the basic requirements after being reviewed by relevant departments, it is recommended to enter the city's priority approval procedure
for Class II medical devices.
Based on the safety of medical devices of the same variety, the registration applicant can analyze and evaluate the clinical trial or clinical data of the same variety of Class II medical devices to prove the safety and effectiveness
of the product.
Accelerate the construction of the Yangtze River Delta sub-center for the technical review and inspection of drugs and medical devices of the State Food and Drug Administration, take innovative products in key areas of the city as the key varieties of priority communication and exchange in the sub-center, provide guidance and services for product review and approval, and accelerate the process of
product launch.
(Responsibilities: Municipal Drug Administration, Municipal Economic Information Commission, Yangtze River Delta Branch Center of Drug Evaluation and Inspection of the State Food and Drug Administration, Yangtze River Delta Branch Center of Medical Device Technical Evaluation and Inspection of the State Food and Drug Administration)
Accelerate hospital admission of innovative products
Actively recommend innovative drugs to enter the national medical insurance drug catalog
.
Promote the use of innovative drugs in the national medical insurance drug catalogue in municipal hospitals, and municipal hospitals shall, within 3 months after the release of the national medical insurance drug catalog, according to clinical needs and hospital characteristics, include the corresponding innovative drugs in the hospital drug supply catalog
as soon as possible on the principle of "should be matched and matched".
The above-mentioned included innovative drugs are included in the budget separately and are not included in the total hospital medical insurance budget
of the year.
Gradually pilot the implementation of the innovation responsibility system in municipal hospitals, and establish and improve performance assessment and incentive mechanisms
such as innovative drug allocation, achievement transformation results, and clinical resource support for R&D needs in municipal hospitals 。 (Responsibilities: Municipal Medical Insurance Bureau, Municipal Health Commission, Municipal Economic Information Commission, Shenkang Hospital Development Center)
Improve the recommendation mechanism for the inclusion of innovative drugs and devices in commercial medical insurance
For newly added Class 1 innovative drugs that have not yet been included in the national medical insurance drug catalogue, but the holder of the drug marketing authorization is an enterprise in the city, as well as innovative medical devices with high clinical use value but not yet included in the scope of medical insurance payment, encourage them to apply for inclusion in the specific high-value drug protection liability scope
of "Huhuibao".
Establish a communication and information sharing mechanism between biomedical enterprises and commercial medical insurance companies, and promote more innovative drugs and devices to enter the commercial medical insurance compensation catalog
.
(Responsibilities: Municipal Medical Insurance Bureau, Municipal Economic Information Commission, Shanghai Banking and Insurance Regulatory Bureau, Municipal Health Commission, Municipal Drug Regulatory Bureau, Shenkang Hospital Development Center)
This policy measure will be implemented from October 31, 2022 and will be valid until October 30, 2027
.
Where this policy measure duplicates other similar policies in the city, it shall be implemented
in accordance with the principle of "superiority, superiority, and non-duplication".
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