China News Service:
If the number of new COVID-19 vaccines approved for the market increases, the whole of society will be concerned about their quality and safety. What measures will the NMPA take to enhance the supervision of vaccine quality? Thank you.
Li Bin:
This question is very clear, so I'd like to invite Mr. Yuan Lin, head of the Department of Drug Regulation of the NMPA, to introduce the situation.
Yuan Lin:
Thank you for your question. This is a very important issue that has generated much interest, and is also related to concerns over safety for people who have been vaccinated. Through years of efforts, and along with the rapid development of the economy and society, China has established a fairly complete vaccine regulatory system, a relatively comprehensive legal system and a comparatively sound vaccine quality standards system. We have implemented good manufacturing practices (GMP) in line with advanced international standards, and China's vaccine regulatory system has twice passed the evaluation of the WHO's national regulatory system. As such, it can be said that our vaccine regulation has been internationally recognized.
Especially since the outbreak of COVID-19, the NMPA has resolutely implemented a series of important instructions given by General Secretary Xi Jinping on COVID-19 vaccines, and implemented decisions and arrangements of the CPC Central Committee and the State Council. In particular, in the aspect of implementing the "four strictest" regulatory requirements for vaccines, a series of strong and effective measures have been taken to ensure the quality and safety of the COVID-19 vaccines.
It is well known that with regards to laws and regulations, China is the only country in the world that has introduced a specific law on vaccine management, which is the Vaccine Administration Law. On that basis, we have formulated a series of supporting rules and regulations and put in place requirements on technical specifications, ensuring that all vaccine-related companies, including distribution companies, as well as vaccination centers and regulation authorities can act in line with relevant laws and rules, and all of our work can be carried out in an orderly manner within the legal framework. To ensure the quality of vaccines, by adhering to the laws, regulations and supervision, and being responsible for the people, we have made it clear that vaccine manufacturers are primarily responsible for ensuring the quality and safety of vaccines. We require that vaccine manufacturers assume the main responsibilities in accordance with the law. They are required to act as follows: First, they must strictly abide by the Good Manufacturing Practice (GMP) for Drugs. Second, they must ensure that products are produced according to approved manufacturing techniques and standards. The process of vaccine manufacturing is relatively complex and missteps can be caused by oversights. Meanwhile, to further ensure the quality and safety of vaccines, we require manufacturers to conduct strict testing before releasing vaccines and take responsibility for pharmaceutical marketing, including strictly following requirements on transport, delivery and cold-chain logistics. At the same time, we require manufacturers to actively collect and analyze information on adverse reactions that occur during vaccination work. The aim of all these measures is to ensure the safety and quality of vaccines throughout the entire management chain.
For regulation authorities, we used a combination of measures to tighten supervision and law enforcement. We just mentioned that four manufacturers have been granted conditional market approval for vaccines. We organized comprehensive and systematic inspection tours of these companies in a timely manner. Meanwhile, we organized inspections of relevant workshops to ensure that they were licensed. We also arranged for expert inspectors from national and local drug regulatory authorities to carry out inspections and spot checks regularly or periodically. One of the important measures we have organized is for a team of at least two inspectors stationed in the manufacturers to supervise different aspects using various measures, to supervise and guide companies to improve their management system and ensure their manufacturing processes are in line with laws and regulations, in a bid to ensure vaccine quality. With the joint efforts and coordinated cooperation with relevant departments, we are working together to use information technology to track vaccine information, monitor suspected adverse reactions during vaccination and offer proper handling, and crack down on vaccine-related crimes and violations in accordance with the law.
By taking various, effective measures, we will ensure the safety of COVID-19 vaccines in a comprehensive manner and lay a solid foundation for the vaccination work. Thank you.
