The Vaccine Administration Law was promulgated in 2019, and entered into force on December 1, 2019.

There are 99 articles in total.

The key points are as follows:

1.This Law shall apply to the development, production, circulation and vaccination of vaccines as well as supervision and administration thereof within the territory of China. (Article 2)

2.The residents living within the territory of China shall legally enjoy the right to inoculate vaccines under the immunization program and perform the obligation of inoculating vaccines under the immunization program. The Government provides vaccines under the immunization program to the residents free of charge.(Article 6)

3.The State organizes vaccine marketing authorization holders, scientific research institutions and medical and health institutions to jointly tackle key problems, and develop vaccines urgently needed for disease prevention and control.(Article 14)

4.A vaccine to be marketed within the territory of China shall be approved by the drug administrative department under the State Council and obtain a drug registration certificate.(Article 19)

5.With respect to a vaccine urgently needed for responding to a major public health emergency or any other vaccines urgently needed as determined by the competent health department under the State Council, if the benefits outweigh the risks upon assessment, the drug administrative department under the State Council may conditionally approve the vaccine registration application.(Article 20)

6.Each batch of vaccines shall, before being sold or imported, be examined and inspected according to the relevant technical requirements by the batch release institution designated by the drug administrative department under the State Council.(Article 26)

7.The State encourages vaccine production enterprises to produce and export vaccines according to the international procurement requirements.(Article 98)