The Regulation and Approval of New Drugs in China

Abstract

Chinese drug legislation, enacted in 1985, requires that new drugs be approved by the national drug regulatory authority before they can be marketed in China. Since enactment of this legislation, China has significantly improved its regulatory review process for new drugs. During the same time period, the pharmaceutical industry in China has shown considerable expansion. With China's membership in the World Trade Organization, the Chinese pharmaceutical industry is experiencing change and will continue to do so. The new Drug Registration Regulation, which is compatible with the World Trade Organization agreement, went into effect on December 1, 2002. This paper reviews China's new drug approval history, regulatory policy and administration, and related issues with respect to China's climate for pharmaceutical innovation and the Chinese pharmaceutical industry. We provide approval data for new chemical entities (NCEs) approved from 1985 through 2000, and draw a picture of China's NCE review policies and the NCE approval process. We also offer views on changes to China's environment for pharmaceutical innovation since joining the World Trade Organization.

Keywords

China World Trade Organization New chemical entity Drug development Pharmaceutical industry

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