CCTV:
What regulatory measures will the authorities take to ensure the quality and safety of COVID-19 vaccines conditionally allowed to enter the market? Should the supervision be stricter and more regulated in terms of conditional market entry?
Chen Shifei:
Thank you for your question. The National Medical Products Administration (NMPA) has always adhered to the "four strictest requirements" in regard to drug safety, and has fully implemented the supervisory tasks for drug quality and safety, including those of vaccines. Vaccines are intended for healthy people. Therefore, we attach great importance to ensuring their quality and safety. Following conditional marketing authorization for COVID-19 vaccines, we have strengthened our supervision in regard to the following aspects to ensure that every vaccine meets quality requirements.
First, quality comes from adequate arrangement and guidance. As early as the research and development stage of vaccines, we actively make arrangements and provide guidelines to the technical institutions directly under the NMPA and provincial drug regulatory authorities, in order to track and guide the relevant work. During the construction of production facilities, we have selected and dispatched competent technicians to provide on-site guidance to the enterprises involved. On the premise of not reducing procedures or lowering the standards, we have issued drug production licenses in a timely way to vaccine manufacturers that meet the required standards. We have ensured that vaccine manufacturers have relevant technologies and management capacity by strictly enforcing the issuing rules of drug production licenses.
Second, in the process of production supervision, the NMPA has acted in accordance with relevant laws, regulations and standards including the Vaccine Management Law, the Pharmaceutical Administration Law and the Good Manufacturing Practice (GMP) of Medical Products. We have intensified supervision over the COVID-19 vaccines' quality together with provincial drug regulatory departments. So far, we have carried out many audits and inspections of the quality and safety of the production sites of the Beijing Biological Products Institute Co., Ltd. under the China National Biotec Group (CNBG) affiliated with Sinopharm. The drug regulator in the locality where the enterprise is located has stepped up its efforts in regard to daily supervision, posted capable professionals to the enterprise for oversight, in order to ensure its compliance in the vaccine production process so that the vaccines are qualified. In addition, we also organized the National Center for Vaccine Inspection to conduct regular inspections on vaccine manufacturers and random checks on vaccines at irregular intervals. What's more, we arranged for the Center for Drug Reevaluation to cooperate with health departments to do a good job in monitoring the suspected adverse reactions to the vaccination. Through these measures, we have supervised enterprises so they earnestly fulfill their primary responsibility for products quality and safety, and organize production in strict accordance with the approved production techniques and quality standards. For each batch of vaccines that leaves the factory, their lot release will be carried out by the drug regulatory authorities. Earlier this year, we began to enhance our lot release capacity to accommodate the production increase following the vaccines' market entry. After strict examination and comprehensive assessment, we have now authorized drug regulatory and inspection institutions in Beijing and Hubei province to undertake the lot release task of COVID-19 vaccines. Therefore, after the vaccines enter the market conditionally, the lot release agencies will carry out strict data review and laboratory tests on each batch of vaccines following relevant regulations and management measures for biological products lot release, so as to ensure that each and every vaccine is qualified.
Finally, we have improved the whole-chain supervision of vaccines. The NMPA, together with the National Health Commission, has established an information technology-based traceability system for vaccines, basically realizing whole-process traceability management of vaccines entering the market. Currently, domestically produced and imported vaccines are tracked during the entire process through self-developed traceability systems or third-party platforms. Thank you.
