Supervision Paired with Innovation: The New Vaccine Administration Law

AuthorSong Jinyang
SONG Jinyang
After the recent vaccine scandal, where Changchun Changsheng,
a Jilin-based biotechnology company produced nearly 500,000
substandard diphtheria, pertussis and tetanus (DPT) vaccines 1
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.2 The Vaccine Administration Law (hereinafter
referred to as VAL) has recently been promulgated at the 11th
meeting of the Standing Committee of the 13th Session of the
National People’s Congress.3
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 Law4
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
(hereinafter referred to as “2016 Vaccine Regulation”)5, in response
to the 2016 vaccine scandal where the vaccine delivery in several
provinces failed to meet the low-temperature requirements. 6
1 Reuters Edit orial, Chinese vaccine maker made 500,000 substandard b aby vaccines , REUTERS
(Aug. 15, 2018), cle/us-china-vaccines-idUSKBN1L014D.
2 Zhao Wenjun ( 赵文君) & Yang Weihan (杨维汉), Wo guo Nidui Yimiao Guanli Dand u Lifa (
国拟对疫苗管理单独立法) [China Plans to Enact Separate Dru g Administration La w], XINHUA NET
(Dec. 23, 2018), cs/2018-12/23/c_1123892044.htm.
3 Draft law stipula tes heav y penalites for fake vaccines, XINHUA NET (Apr. 2 3, 2019 ), -04/23/c_137999254.htm.
4 Yaopin Guanli Fa (药品管理法) [Drug Admi nistration Law] (promulgated by the Stan ding
Comm. Nat’l People’s Cong., Sep. 20, 1984, effe ctive Jul. 1, 1985) (2015) (Chinalawinfo).
5 Yimiao Liutong he Yufangjiezhong Guanli Tiaoli (疫苗流通和预防接种 管理条例) [Regulation
on the Administration of Circulatio n and Vaccination of Vaccines] ( promulgated by St . Council, Mar.
24, 2005, effective Jun. 1, 2005) (2016) (Chinala winfo).
6 Feifa Jingying Yimiao Ansuo She 24 Shengshi Gonganbu: Jiang Quanli Zhenban ( 非法经营疫苗
案索涉24省市 公安部:将全力侦办) [I llegal Vaccine Business Involves 24 Provinces and Cities
Ministry of Public Security: Will Work it s Best on the Case], IFENG (Mar. 20, 2016), http://finance.ifen

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