International Journal of Pharmaceutical Medicine

, Volume 20, Issue 6, pp 361–366 | Cite as

Current Status of the Implementation of Good Clinical Practice in China

Special Section on Medicines Development in China Focus on China

Abstract

If a medical institution in China wishes to carry out clinical studies on humans they must first gain accreditation from the relevant regulatory department of the State Council.

The main purpose of this article is to provide readers with background information on the introduction of good clinical practice (GCP) along with information on the development and management methods currently employed in drug research in China. We then analyse the current issues for GCP implementation in China so as to help improve the implementation of these regulations.

Keywords

Good Clinical Practice State Council Drug Research Dermatophytosis Good Laboratory Practice 

Notes

Acknowledgements

I would like to express my sincere appreciation to Ms Rong Zhang, my colleague from the Centre for Certification of Drugs, State Food and Drug Administration, P. R. China, for the translation of this article into English.

I would also like to express my thanks to the following training centres for kindly providing the relevant data needed for this article: Peking University Health Science Center; West China Hospital, Sichuan University; Medical Center of Fudan University; Sun Yat-sen University of Medical Sciences; Xiangya Hospital of Centre-south University; China Academy of Chinese Medical Sciences; Guangzhou University of Traditional Chinese Medicine; Chengdu University of Traditional Chinese Medicine; and The Training Centre, State Food and Drug Administration.

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Copyright information

© Adis Data Information BV 2006

Authors and Affiliations

  1. 1.Centre for Certification of DrugsState Food and Drug AdministrationBeijingPeople’s Republic of China

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