China Vaccine Production and Distribution Rules were released by the National Medical Products Administration (NMPA) on July 8, 2022 and came into effect immediately.
The new Rules on the Administration of Vaccine Manufacturing and Distribution (“RAVMD”) is a more detailed implementation regulation on vaccine production, distribution, change and supervision based on the Vaccine Administration Law (VAL).
The China Vaccine Production & Distribution Rules contain a total of 7 chapters (44 articles in total), and the main contents are summarized below.
Production requirements
Marketing Authorization Holders (MAH) shall be primarily responsible for the safety, efficacy and quality control of vaccines. The MAH should have full capacity for the vaccine production. If the required production capacity exceeds the MAH’s vaccine production capacity, the MAH can apply to the NMPA for entrusted production, but one of the following three conditions needs to be satisfied:
- The industry and information management department of the State Council requests the creation of vaccine reserves, and believes that the holder’s existing production capacity cannot satisfy the requirements;
- The health management department of the State Council proposes an urgent need for disease prevention and control, and believes that the current production capacity of the holder cannot satisfy the requirements;
- Production of polyvalent vaccines.
If you would like to know about the application process for entrusted vaccine production (including application dossier requirements, acceptance, review and approval), please contact us for more information.
Vaccine circulation management
Provincial disease prevention and control institutions are responsible for formulating vaccine use plans in their administrative regions, and vaccine marketing license holders are responsible for distributing vaccines to disease prevention and control institutions or to inoculation units designated by disease prevention and control institutions.
In principle, overseas vaccine holders should designate a domestic drug wholesale enterprise with cold chain drug quality assurance capabilities to sell their vaccines of the same variety uniformly.
Marketing license holders can entrust enterprises to distribute and store vaccines in regions as long as the entrusted distribution enterprise meets the transportation and storage conditions of refrigerated and frozen medicines in accordance with the Quality Management Standards for Pharmaceuticals.
In principle, the marketing license holder may not select more than 2 vaccine regional distribution companies within the same provincial administrative region.
Companies that accept entrusted distribution are not allowed to recommission.
In the process of circulation management of imported vaccines, if major deviations or major quality problems that may affect the quality of vaccine products are found, the domestic agent designated by the overseas vaccine holder shall report to the provincial drug supervision and administration department where the port of importation is located.
Other provisions
The state implements a strict access system for vaccine production and strictly controls the opening of new vaccine manufacturing enterprises. This means that under the new regulatory environment, the entry barriers for companies to obtain production licenses will be stricter.
The final chapter of RAVMD specifies that vaccines that have been exported from China are prohibited from being re-imported into the country. It also further explained that when overseas vaccine holders entrust Chinese enterprises to manufacture vaccines, the vaccines should be registered domestically as localized products instead of imported products. Meaning that a domestic owner should be designated in advance to apply for the registration.
Further information
Please access the full rules on China vaccine production and distribution here:
https://www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjyp/20220708185734126.html
If you would like more information on vaccine production and distribution in China or our registration and CRO services for pharmaceuticals, medical devices, IVDs, cosmetics, health foods, industrial or consumer goods, please contact us.
