WHO supports Chinese vaccine players to meet global standards
The regulation of vaccines is extremely important. It is the main means for the government to ensure that vaccines produced and used in China are safe, high quality and effective. This incident shows that potential risks can be circumvented when regulation is effective. Effective drug production quality management and regulation is to prevent problems and ensure vaccine quality. But once problems are discovered, regulators must take action. WHO commends the China State Food and Drug Administration for taking swift and transparent action to stop its production and investigate the incident.
WHO conducted two assessments of China’s national drug regulatory authorities in 2010 and 2014. The results show that the national drug regulatory department has met the standards of the WHO’s fully functioning regulatory body and has clearly promised to continue to improve. WHO welcomes the continued cooperation of the China National Food and Drug Administration with WHO’s strengthening of national regulatory authorities, which has been under way for nearly 20 years. This incident is undoubtedly regrettable, but the incident was discovered by flight inspection. It also shows that the system supervision and onsite inspection of the regulatory authorities can effectively protect people’s health.
WHO reiterates that reliable vaccines are essential for disease prevention and encourages countries to continue to adopt this cost-effective public health intervention. China’s expanded immunization program has been effective, allowing China to achieve polio-free status and significantly reducing vaccine-preventable diseases such as measles, mumps, rubella, hepatitis A and hepatitis B among children. To this end, WHO also supports Chinese vaccine manufacturers to meet international standards and WHO pre-certification requirements.
- Dr. Gao Li, World Health Organization
Representative in China