A Snapshot of the Evolution of Pharmaceutical Regulations in China and Hong Kong
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A Snapshot of the Evolution of Pharmaceutical Regulations in China and Hong Kong
Bing Bing Lin, PLD, MIA Adjunct Assistant Professor, Department of Business Administration and Department of Healthcare Management, Chang Gung University. Tao Yuan, Taiwan
Kry Words Pharmaceutical regulatory system; Regulatory harmonization; Regulatory consultation; China; Hong Kong Corrrspondrncr Addrrss Dr. fling fling Lin, 9F- I , #332, Sec. I , Tung-Hwa South Road, Taipei ( I 06), Taiwan (email: a332199@ gmail.com).
China’s foreign exchange reserves topped the world with USS2.13 trillion by the end ofJune, 2009. China has emerged as a bigpharmaceutical market. Since 2001, China has introduced significant regulatory changes to strive to become compatible with international standards. These include restructuring of the State F d and Drug Administration and amending pharmaceutical regulations. The developments and updates on the Pharmaceutical regulatory
INTRODUCTION According to an estimate in July 2008, China has a population of 1,330,044,544, a total land area of 9,596,960 km2,with US$6,100 GDP per capita (gross domestic product at purchasing power parity) (1). Hong Kong has a population of 7.018,636,on a total area of 1,092 km2, with US$45,300 GDP per capita. According to the People’s Bank of China, China’s foreign exchange reserves topped the world with US$2.l3 trillion by the end of June 2009 (2). China is one of the most promising emerging pharmaceutical markets. All of the top 10 pharmaceutical companies are trying to target the Chinese sector. The drug market in China in 2007 was US$lZ6 billion. It has been growing at a rate of 30% and is expected to continue its expansion for the coming years, becoming potentially the fifth largest drug market in the world by 2011 (3). Since 2001, China has introduced significant regulatory changes to strive to become compatible with international standards. These include reorganizing the former State Drug Administration into the State Food and Drug Administration (SFDA). The developments and updates on the pharmaceutical regulatory systems in China and Hong Kong are of great interest to researchers, regulators and policy makers in pharmaceutical industry. However, it seems limited related research is being reported. Therefore, a snapshot of the evolution of pharmaceu-
systems in China and Hong Kong are of great interest to pharmaceutical manufacturers and researchers. Data from recent ongoing clinical trials in Asia along with the pharmaceutical regulatory challenges and opportunities for China and Hong Kong are described. Regulatory cooperation among regional Asian c a n tries may result in a win-win situation and a bright fiture for all.
tical regulatory systems in China and Hong Kong is described in this article.
EVOLUTION OF PHARMACEUTICAL R E G U L A T O R Y S Y S T E M S IN C H I N A On December 1, 2001, the “Drug Administration Law of the People’s Republic of China” was promulgated. China earnestly fulfilled its commitments to the World Trade Organization (WTO) and implem
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