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Related Experiment Videos

Drug control authorities in China.

Li Hui Zhen1

  • 1International Medical & Commercial College, China Pharmaceutical University, 37#, Nanjing, Jiang Su, 210009, China. lihuizhenCPU@hotmail.com

The Annals of Pharmacotherapy
|January 27, 2004
PubMed
Summary
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Drug registration application in China.

Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiquesยท2003
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China

Area of Science:

  • Pharmaceutical policy
  • Regulatory affairs
  • Health economics

Background:

  • Understanding China's drug control framework is crucial for market entry.
  • The landscape involves multiple regulatory bodies with distinct responsibilities.

Purpose of the Study:

  • To outline the key drug control authorities in China.
  • To identify their respective roles in drug administration, pricing, and advertising.
  • To acknowledge challenges and potential solutions within the regulatory system.

Main Methods:

  • Review of China's drug control authorities.
  • Analysis of the State Food and Drug Administration (SFDA), State Development and Reform Commission (SDRC), and Provincial Administrations for Industry and Commerce and Food and Drug Administration.

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Main Results:

  • Key authorities include SFDA (drug administration), SDRC (drug pricing), and provincial bodies (advertisement regulation).
  • These authorities have achieved successes but face challenges requiring solutions.

Conclusions:

  • The Chinese drug regulatory system presents challenges that other countries may encounter.
  • Understanding these dynamics is vital for international pharmaceutical companies entering the Chinese market.