Advances in Biopharmaceutical Technology in China
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Chapter 7:   Pharmacy and Drug Administration in China

Jiang Xuehua
The West China School of Pharmacy
Sichuan University
No. 17 Section 3 Renmin Nanlu CHENGDU CHINA
TEL: 86-28-85501370
E-mail: jxh1013@vip.163.com

About the Author:
Jiang Xuehua, Ph.D. is a doctor of science and professor with the West China School of Pharmacy, Sichuan University. He was born in 1956, and from March 1978 to December 1981 he studied at the Department of Pharmacy at Sichuan Medical College, and received his bachelor of medicine degree. From 1991 to 1994, he studied pharmaceutics at the School of Pharmacy under the West China University of Medical Sciences, and received the degree of doctor of science. From 1982, he started to teach in the School of Pharmacy of Sichuan University (predecessors include the Department of Pharmacy of Sichuan Medical college, and the School of Pharmacy under the West China University of Medical Sciences). As a Ph.D. tutor in clinical pharmacology and Pharmacy Administration, he is primarily engaged in research and teaching of pharmacy administration and clinical pharmacy. The major academic titles he holds include: member of the Standing Committee of the Pharmacy Administration Committee of the Chinese Hospital Association, member of the National Advisory Committee on Clinical Pharmacy in China's Higher Education, Deputy Director of the Advisory Committee on Training of Clinical Pharmacists under the Chinese Hospital Association, consultant of the Working Committee on Pharmacy Administration in Sichuan Hospitals, member of the Drug Metabolism Commission under the Chinese Pharmacological Society, Vice Chairman of Sichuan Branch of the Chinese Pharmaceutical Association, and Director of Sichuan Clinical Pharmacy Association.

Abstract:
This chapter introduces the history of China's drug administration, from the gradual establishment of drug supervision and administration after the founding of the People's Republic of China, to the modern legislation of China's drug administration. This chapter, in accordance with the regulations set forth in the revised Drug Registration Law, which took effect in 2005, comprehensively introduces administrative measures for the registration of new drugs, including classification of chemical drugs, biological products, traditional Chinese medicine, natural drugs, basic requirements on new drug applications, approval for clinical research and production of new drugs, as well as the monitoring period and technical transfer of new drugs. In particular, this chapter introduces the application for registration of imported drugs and the application for sub-packing of imported drugs. Furthermore, this chapter introduces pre-clinical drug research, and the requirements of Good Laboratory Practice ("GLP") and Good Clinical Practice ("GCP"). In conclusion, this chapter briefly introduces the administrative protection of pharmaceuticals and the relevant procedures for approval, as well as the current status of drug patent protection in China.

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