The Regulation and Approval of New Drugs in China
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The Regulation and Approval of New Drugs in China Rongling Deng and Kenneth I Kaitin Drug Information Journal 2004 38: 29 DOI: 10.1177/009286150403800105 The online version of this article can be found at: http://dij.sagepub.com/content/38/1/29
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DRUG REGULATION
29
The Regulation and Approval of New Drugs in China
'WHO Fellow, Tufts Center for the Stub ofDrug Development, Tufts Universitv, Boston, Massachusetts b b d 5 0 y9.1 Kenneth I Koitin, PhD Director. Tufts Centerfor the Study of Drug Development, Tufts University, Boston, Massachusetts
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Key Words China; World Trade Organization; New chemical entity; Drug development; Pharmaceutical industry
Correspoidence Address Kenneth I Kaitin. PhD, Director. Tufts Center for the Study of Drug Development, 192 South St., Suite 550, Boston, MA 02111 (e-mail: [email protected]). 'Ms. Deng is Senior officer at the Sichuan Drug Administration, Chengdu. China. She conducted this research while on a hvo-year World Health Organisation fellowship at the Tufts Center for the Study of Drug Development.
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 significantlyimproved its regulatory review process for new drugs. During the same time period, the pharmaceutical industry in China has shown considerableexpansion. With China's membership in the World Tmde 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
IN T R O D U (TI 0 N China's pharmaceutical industry has made significant progress since the early 1990s. As the industry developed, intellectual property became more important and intellectual property protection has improved, especially after China gained membership in the World Trade Organization (WTO) on December 11, 2001. China's pharmaceutical market offers great potential to both national drug firms and foreign firms interested in doing pharmaceutical research and development in China. In this paper, we review China's history of NCE regulatory policy and administration, and discuss related issues with respect to China's climate for pharmaceutical innovation and changes in the Chinese pharmaceutical industry. In our analyses, we use the Tufts Center for the Study of Drug Development's definition of an NCE that is, any
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