Expanded authorization for batch release of biological products accelerates product market access.

Release time：

2023-03-02

To enhance the efficiency of batch release for biological products (vaccines), the National Medical Products Administration has decided, on the basis of a thorough risk assessment, to progressively expand the scope of provincial drug regulatory authorities’ testing and inspection institutions authorized to carry out batch release 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, on the basis of a thorough risk assessment, to progressively expand the scope of provincial drug regulatory authorities’ testing and inspection institutions authorized to carry out batch release for biological products (vaccines) as well as the range of vaccine products covered. The time limit for batch release of seasonal influenza vaccines and other such products will be shortened to no more than 45 working days. This measure will effectively reduce the waiting period for vaccines and other biological products to enter the market, thereby ensuring adequate supply. For vaccine manufacturers, faster market access will improve operational efficiency and help enhance the timeliness and coverage of vaccination in China, providing stronger safeguards for public health security. 