Meeting today's global health challenges requires having reliable sources of high-quality medical products — vaccines, drugs, and diagnostics — at affordable prices for people in developing countries. Despite huge growth in the production of medical products in China and significant investments in research and development, vaccines and medicines manufactured in China comprise less than 4 percent of the products prequalified by the WHO, compared with 67.5 percent from India.
WHO prequalification is often required before medical products are eligible for purchase by developing countries and by multilateral organizations such as Gavi, UNICEF, and UNITAID. Disincentives for Chinese manufacturers to pursue WHO prequalification of their products include differences between the standards and practices of China and the international standards and practices of the WHO prequalification program.
We work with the WHO and other partners to provide technical assistance and other support to the Chinese regulatory bodies to align Chinese regulations and standards with international requirements and improve its overall regulatory capacity to achieve its reform goals. This will enable more high-quality, affordable Chinese-manufactured products to quickly pass WHO prequalification and become accessible to the developing world, thus greatly strengthening the ability of the global community to address severe health challenges.