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国务院常务会议解读:提高审评审批质效 加快临床急需药品医疗器械上市

Interpretation of the State Council executive meeting: Improve the quality and efficiency of review and approval, and accelerate the market launch of urgently needed clinical Pharmaceutical and medical instruments.

Breakings ·  Dec 24, 2024 21:19

The executive meeting of the State Council held on the 23rd focused on the regulatory reform of Pharmaceutical and medical instruments to promote high-quality development of the pharmaceutical industry. This includes improving the quality and efficiency of review and approval, accelerating the review and approval process for urgently needed clinical Pharmaceutical and medical instruments, and other series of reform measures to deepen the review and approval of Pharmaceuticals and medical instruments. Industry insiders believe that deepening the reform of the entire process of Pharmaceutical and medical instruments regulation aims to create a favorable policy environment that facilitates innovation. The emphasis on 'the entire process' means that relevant reforms will involve every link from research and development, production, circulation to use, striving to construct a complete chain that supports innovative development, ultimately assisting the country in transforming from a 'large nation' in the pharmaceutical field in terms of scale to a 'strong nation' with core competitiveness and high-level technology, enhancing its position in the global pharmaceutical industry landscape. It is worth mentioning that the reform measures mention 'improving the quality and efficiency of review and approval,' which mainly focuses on the key stages before Pharmaceuticals and medical instruments enter the market, reducing unnecessary process redundancy, optimizing review and approval processes, and tilting review resources, which helps shorten the time cycle from research and development to market launch, allowing clinically valuable results to be brought to market more quickly to benefit patients. (Xinhua News Agency)

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