This notified document is a revision to Provisions for Lot Release of Biological Products, issued in 2004. It includes 7 chapters, 49 articles. It specifies that vaccines, blood products and blood screening agents should be subject to quality assessment such as mandatory examination and inspection by quality control laboratories of drugs designated by CFDA. And only the qualified ones can be imported to and/or distributed in China. Main changes in this revision include: adding a chapter of lot Release institutes, defining the time-limit of the whole chain and the situation under which on-site inspection shall be conducted.