In the Administrative Measures, the term “batch release biological products” refers to the issuance of release certificate by designated batch release agencies for biologics that have undergone review and testing and meet the eligibility criteria.

The applicable biologics refer to vaccines, blood products, in vitro diagnostic reagents for blood source screening, and other biologics that have received marketing authorization from the NMPA.

Biologics cannot be sold or import without completing the batch release process, unless they are exempted from batch release requirements.

The applicants for batch release should be drug marketing authorization holders (MAHs). Foreign MAHs should designate a Chinese corporate entity to handle the batch release application.