Authorization for batch release of biological products is expanded, accelerating the product launch process.
Release time:
2023-03-02
To enhance the efficiency of batch release for biological products (vaccines), the National Medical Products Administration has decided, based on a thorough risk assessment, to gradually expand the scope of provincial drug regulatory authorities authorized to carry out batch release inspections and testing for biological products (vaccines), as well as the range of product types covered.
To enhance the efficiency of batch release for biological products (vaccines), the National Medical Products Administration has decided, based on a thorough risk assessment, to gradually expand the scope of provincial drug regulatory authorities authorized to carry out batch release inspections and testing for biological products (vaccines), as well as the range of product types covered. The batch release timeframe for products such as seasonal influenza vaccines will be shortened to within 45 working days. This measure will effectively reduce the waiting time for biological products, including vaccines, to reach the market, thereby ensuring stable supply. For vaccine manufacturers, faster market access will improve operational efficiency and help enhance both the timeliness and coverage of vaccination efforts in China, providing stronger safeguards for public health security.
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