Authorization for batch release of biological products expanded, accelerating product launch timelines.
Release date:
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—both in terms of provincial drug regulatory agencies authorized to conduct inspections and testing, as well as the specific vaccine varieties eligible for this process.
To enhance the efficiency of batch release for biological products (including 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 conduct inspection and testing for batch release of biological products (vaccines), as well as the range of products covered. For seasonal influenza vaccines and other such products, the batch release timeline will be shortened to within 45 working days. This initiative will effectively reduce the time required for vaccines and other biological products to reach the market, ensuring a steady supply. For vaccine manufacturers, faster product availability will boost operational efficiency, enabling companies to bring their innovations to market more swiftly. Additionally, this move will help improve the timeliness and coverage of vaccination programs in China, providing stronger safeguards for public health security.
Related News
Company Address: Zone C, Specialized & Innovative Chemical Industry Incubation Base, West Section of Yili River Street, No. 436, Qinchuan Town, Qinchuan Park, Lanzhou New Area, Gansu Province
Mobile Phone Official Website