In March 2011, an assessment by the World Health Organization (WHO) revealed that China’s vaccine regulations are now complying with international standards. This implies that vaccine manufacturers in China can now submit applications to have their vaccines pre-qualified by WHO.
China is the 36th vaccine producing country in the world where its regulatory system has been assessed as “qualified” by the WHO. The timeline for WHO to pre-qualify vaccines from China ranges between 1 and 2 years. Currently, China has 36 vaccine producing plants that produce 49 kinds of vaccines against 27 diseases.
China had previously failed WHO’s vaccine regulatory system assessment in 1999, 2001 and 2005. Since then, the country had taken steps to enhance its vaccine regulation standards. The new Good Manufacturing Practice (GMP) code adopted by the SFDA with effect from March 1, 2011, contains stricter requirements for vaccine production to ensure production of quality vaccines.
In early 2011, the SFDA also issued the Notice for Further Strengthening the Supervision of Quality and Safety of Vaccines. This Notice outlined some important initiatives which affect the R&D, manufacturing and distribution of vaccines in China. These initiatives include forming an expert panel to review industry policies, quality standards and quality assurance systems of vaccine manufacturers. The SFDA also requires companies to have detailed records of the source, history and biological characteristics of microbial or pathogenic strains for vaccine development.