China News Service, December 31. Chen Shifei, deputy director of the State Drug Administration, said on December 31 that the State Drug Administration attaches great importance to ensuring the quality and safety of vaccine production.
After the conditional approval of the new coronavirus vaccine for marketing, supervision will be strengthened from many aspects to ensure that each vaccine meets the quality requirements.
On the 31st, the Joint Prevention and Control Mechanism of the State Council held a press conference on the conditional listing of the new coronavirus vaccine and related work.
A reporter asked at the meeting, what regulatory measures will the regulatory authorities take to ensure the quality and safety of vaccines?
Should conditional listing be more stringent and regulated in terms of supervision?
Chen Shifei stated that the State Food and Drug Administration has always adhered to the "four strictest" requirements for drug safety and fully implemented drug quality and safety supervision work including vaccines, especially vaccines are used for healthy people, so the State Food and Drug Administration attaches great importance to guarantees The production quality of the vaccine is safe.
After the conditional approval of the new coronavirus vaccine for marketing, supervision will be strengthened from the following aspects to ensure that each vaccine meets the quality requirements.
First of all, quality comes from design.
As early as the vaccine research and development stage, we actively deployed and guided the technical institutions directly under the National Medical Products Administration and the provincial drug regulatory authorities to actively carry out follow-up services, rely on the guidance, and seamlessly connect with the enterprise during the workshop construction stage, and select capable personnel Technical personnel to provide on-site guidance to the enterprise.
On the premise that the procedures and standards are not reduced, vaccine manufacturers that meet the requirements of the standards shall be issued with drug production licenses in a timely manner.
Through strict conditions for the issuance of drug production licenses, to ensure that vaccine manufacturers have technical conditions and management capabilities.
Second, in the production supervision process, the State Food and Drug Administration has taken the following actions in accordance with the "Vaccine Management Law", "Drug Administration Law" and "Drug Production Quality Management Practices" and other relevant laws, regulations and standard requirements:
The first is to strengthen the quality supervision of the new coronavirus vaccine together with provincial drug regulatory authorities.
At present, quality and safety audits and inspections have been carried out on the production site of Sinopharm Zhongsheng Beijing Company for many times. The local drug regulatory authorities have also increased their daily supervision and sent professional professionals with strong business capabilities to Sinopharm Zhongsheng Beijing Company to reside in the company. Carry out supervision activities to ensure compliance with the vaccine production process and ensure that vaccine products are qualified.
The second is to organize the National Vaccine Inspection Center to conduct regular inspections of vaccine manufacturers and conduct random inspections of vaccine products.
The third is to organize the National Drug Evaluation Center to cooperate with the health department to do a good job in monitoring the suspected abnormal response of vaccination.
Chen Shifei said that through the above-mentioned measures, the company will supervise enterprises to fulfill their main responsibility for quality and safety, and organize production in strict accordance with the approved production process and quality standards.
For each batch of vaccines that leave the factory, the drug regulatory authority shall implement batch release.
At the beginning of the year, we began to deploy the expansion of batch issuance capacity building, so that the batch issuance capacity can adapt to the increase in production after the vaccine is launched.
After strict assessment and comprehensive evaluation, the drug regulatory and inspection agencies of Beijing and Hubei Province have been granted to undertake the batch issuance of the new crown vaccine.
Therefore, after the vaccine is put on the market conditionally, the batch issuing agency will implement strict data review and laboratory testing for each batch of vaccines in accordance with relevant regulations and the management methods for batch issuance of biological products to ensure that each vaccine is qualified.
Chen Shifei emphasized that the entire chain of vaccine supervision has also been strengthened.
The State Food and Drug Administration, in conjunction with the National Health Commission, has established a vaccine information traceability system, and has basically realized the traceability management of the entire vaccine market.
At present, domestic vaccine manufacturers and imported vaccines have implemented full traceability through self-built traceability systems or third-party platforms.