I. Introduction

After the recent vaccine scandal, where Changchun Changsheng, a Jilin-based biotechnology company produced nearly 500,000 substandard diphtheria, pertussis and tetanus (DPT) vaccines rendered the country in the grip of nationwide concern for vaccine safety, the central government proposed a separate legislation for vaccine administration to ensure the authority and stability of vaccine supervision. The Vaccine Administration Law (hereinafter referred to as the “VAL”) has recently been promulgated at the 11th meeting of the Standing Committee of the 13th Session of the National People’s Congress.

Before this separate vaccine administration law was enacted, the administration and supervision of vaccines are largely dependent on general drug administration laws such as Drug Administration Law and product standards such as Good Manufacturing Practice for Drugs (2010 Revision). The State Council amended the Regulation on the Administration of Circulation and Vaccination of Vaccines (the hereinafter referred to as the “2016 Vaccine Regulation”) , in response to the 2016 vaccine scandal where the vaccine delivery in several provinces failed to meet the low-temperature requirements. Nevertheless, the recent vaccine scandal brought attention to certain supervision loopholes that require a separate legislation to fill.

As a special kind of drugs, vaccine often demands more stringent production and storage condition. This makes safety the primary focus of the VAL. In addition, the VAL upholds the strategic and the welfare nature of vaccines, and stipulates innovative measures to foster vaccine development.