The impact of drug administration in USA, Europe and Japan on the reform plan in China

doi:10.5246/jcps.2014.05.045

Journal of Chinese Pharmaceutical Sciences ›› 2014, Vol. 23 ›› Issue (5): 324-329.DOI: 10.5246/jcps.2014.05.045

• Drug administration column • Previous Articles Next Articles

The impact of drug administration in USA, Europe and Japan on the reform plan in China

Xiaoyuan Zheng¹, Shixia Zhang², Song Yang¹, Yanyan Li¹, Bin Jiang^1*

1. Department of Administrative and Clinical Pharmacy, School of Pharmaceutical Sciences, Peking University Health Science Center, Beijing 100191, China
2. China Food and Drug Administration, Beijing 100053, China

Received:2013-09-26 Revised:2013-10-19 Online:2014-05-23 Published:2013-11-20
Contact: Tel.:13601100121; E-mail: binjiang@bjmu.edu.cn
Supported by:
National Social Science Fund (Grant No.13BGL141).

Abstract

Abstract:

It is critical to ensure the safety and efficacy of human drugs through drug administration. Drug administration has a long history in developed countries, such as USA, European Union and Japan, and has achieved great success. In this study, we summarized the important changes in the practice of drug administration in USA, European Union and Japan since 1990s. We also discussed how these changes and experience could be applied in the reform plan in drug administration in China Food and Drug Administration (CFDA). Our suggestions on future developmentofCFDA include improving post-market surveillance, advancing regulatory science, strengthening service-oriented regulation, and international cooperation.

Key words: Drug administration, International drug administration, China drug administration

CLC Number:

R954

Supporting:

Xiaoyuan Zheng, Shixia Zhang, Song Yang, Yanyan Li, Bin Jiang. The impact of drug administration in USA, Europe and Japan on the reform plan in China[J]. Journal of Chinese Pharmaceutical Sciences, 2014, 23(5): 324-329.

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The impact of drug administration in USA, Europe and Japan on the reform plan in China

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