Measures for the Administration of the Batch Issuance of Biological Products
Article 1 In order to strengthen the supervision and administration of biological products, regulate the approval and issuance of biological products, and ensure the safety and effectiveness of biological products, these Measures are formulated in accordance with the relevant provisions of the Pharmaceutical Administration Law of the People's Republic of China (hereinafter referred to as the Pharmaceutical Administration Law) and the Vaccine Administration Law of the People's Republic of China (hereinafter referred to as the Vaccine Administration Law). Article 2 The term "batch issuance of biological products" as mentioned in these Measures refers to the activities of the SDA to review and inspect the vaccine products, blood products, in vitro diagnostic reagents for blood source screening and other biological products specified by the SDA that have been approved for marketing, and to issue batch issuance certificates to those that meet the requirements before each batch of products is marketed or imported.
Vaccine Administration Law of the People's Republic of China
Article 1 This Law is formulated with a view to strengthening the administration of vaccines, ensuring the quality and supply of vaccines, standardizing preventive inoculation, promoting the development of the vaccine industry, safeguarding public health and safeguarding public health safety.