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The China Food and Drug Administration (CFDA) announced its official accession to the International Council for Harmonization (ICH) as a new regulatory member on June 19. This is widely seen as a milestone for China’s medical care industry, and will likely give Chinese patients earlier access to new medications produced in other countries.
“ICH is most famous for its guidelines, which encompass everything needed for the registration of new medications. The guidelines cover medicine quality, efficacy, security and many other aspects. ICH sets the technical standards for medication development, production, use and evaluation,” said Chen Hao, a researcher at Tongji Medical College under Huazhong Universitiy of Science and Technology.
At a press conference held on June 19, Yuan Lin, director of the Department of International Cooperation of CFDA, stressed the significance of the accession: “By joining ICH, China vows to gradually switch to and implement the highest medical standards and guidelines in the world. We’ll actively take part in rule-making, shorten the time before new medicines enter China, and enhance the innovation and competitiveness of Chinese medical companies.”