China's Vaccine Regulatory System Appraises Through WHO

Business News Agency March 2 News Lavalli Berggabi, head of the World Health Organization's Vaccine Surveillance System Assessment Expert Group, announced in Beijing on the 1st that China's vaccine regulatory system has passed the WHO assessment and has become the world's 36th qualified regulatory system. Vaccine producing countries.

According to reports, the WHO vaccine regulatory system assessment is an important standard to measure the quality of a country's drug control and vaccines, and has been widely recognized by the international community. Whether or not WHO's standards and requirements can be met, through its formal assessment, is a comprehensive examination of a country's drug regulatory capabilities.

Lavaly Berggabi pointed out that the National Food and Drug Administration's vaccine regulatory system has been verified to meet international standards and meet WHO's requirements for the national vaccine regulatory system, which can play a good regulatory role.

According to reports, during the assessment, WHO experts carried out seven major assessments of China's vaccine regulatory system based on various standards, including the national regulatory system, listing licensing work, post-marketing supervision, including post-inoculation adverse reaction monitoring, and batch approval. Administration of issuance, laboratory management, supervision and inspection of production sites and distribution channels, and authorization and supervision of clinical trials. Experts also went to Beijing, Shanghai, Hebei, Jiangsu and other places to inspect the local vaccine regulatory agencies.

In the assessment, China issued two batches of batch approval and laboratory management, and the other five were also high scores. Shao Mingli, director of the State Food and Drug Administration, said that the results showed that China's pharmaceutical supervision and management system has made great progress and has been recognized by the international community. It also shows that China's vaccine product quality assurance work is strictly regulated.

The representative of the WHO in China, Lan Ruiming, pointed out that through WHO's assessment, it means that China's regulatory authorities have affirmed their ability to ensure the quality and reliability of vaccines that enter the market. At the same time, Chinese vaccine manufacturers will be able to apply for pre-certification of WHO-specific products in the future.

It is reported that pre-certification is a guarantee that a particular vaccine meets international standards for quality, safety, and effectiveness, and is a prerequisite for manufacturers to supply vaccines to other countries through UN procurement agencies. The National Vaccine Surveillance System through the WHO assessment is a precondition for the application of pre-certification by domestic vaccine companies.

According to statistics, there are 36 vaccine production enterprises in China, capable of producing 49 kinds of vaccines for preventing 27 kinds of diseases, with an annual production capacity of nearly 1 billion doses.

Lan Ruiming said that China's vaccine industry is large and can produce a variety of vaccines at affordable prices. "In the near future, Chinese vaccine companies will make outstanding contributions to solving global vaccine demand."