An Analysis of New Drug Examination and Approval System of PRC

Abstract

This paper analyzes the new drug examination and approval systems before and after the Measures was amended in 2007 and evaluates the effectiveness of the 2007 Amendment. In Part One, this paper introduces the new drug examination and approval system before the Measures were amended in 2007 and analyzes its disadvantages. Part Two of the paper describes the changes brought by the 2007 Amendment to the Measures and evaluates their effectiveness with regard to drug safety. Part Three discusses the impacts of the Agreement between the Department of Health and Human Services of the United States of America and the SFDA of the People’s Republic of China on the Safety of Drugs and Medical Devices on Chinese new drug regulation system. In the end, the author concludes that although the tendency of stricter supervision of government authority is obviously beneficial for the guarantee of drug safety, the effective implementation of the legal schemes is still a big issue in China.