Vaccines Administration Law in China

China
On 29 June 2019, the Standing Committee of the National People’s Congress of the People’s Republic of China (the “PRC”) promulgated the PRC Vaccines Administration Law (the “Vaccines Administration Law”). The Vaccines Administration Law will come into effect on 1 December 2019, i.e. on the same day when the newly revised PRC Drug Administration Law promulgated on 26 August 2019 (the “Revised Drug Administration Law”) will come into effect.

The Vaccines Administration Law has altogether eleven chapters, i.e., General Provisions, Vaccine Development and Registration, Vaccine Production and Lot Release, Vaccine Circulation, Vaccination, Monitoring and Handling of Adverse Event to Vaccination, Post-market Management, Safeguard Measures, Supervision and Administration, Legal Liabilities, Supplementary Provisions with in total 100 articles.

Before this Vaccines Administration Law is promulgated, the relevant provisions regarding the administration of vaccines are stipulated in the PRC Drug Administration Law, the Prevention and Treatment of Infectious Diseases Law of the PRC, the Administrative Regulations on the Circulation of Vaccines and Vaccination of the PRC and other relevant laws and regulations. According to Article 2 of the Vaccines Administration Law, vaccines development, production and circulation, vaccination and supervision and administration within the territory of the PRC shall be subject to this Vaccines Administration Law. If there are any issues which are not prescribed in this Vaccines Administration Law, the provisions of the PRC Drug Administration Law, the Prevention and Treatment of Infectious Diseases Law of the PRC and other laws and regulations shall apply. The current regulations of vaccines, especially the Administration Regulations on the Circulation of Vaccines and Vaccination of the PRC should be amended to be in line with the Vaccines Administration Law.

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