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Abstract

China's foreign exchange reserves topped the world with US$2.13 trillion by the end of June, 2009. China has emerged as a big pharmaceutical market. Since 2001, China has introduced significant regulatory changes to strive to become compatible with international standards. These include restructuring of the State Food and Drug Administration and amending pharmaceutical regulations. The developments and updates on the pharmaceutical regulatory 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 countries may result in a win-win situation and a bright future for all.

Keywords

Pharmaceutical regulatory system Regulatory harmonization Regulatory consultation China Hong Kong

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A Snapshot of the Evolution of Pharmaceutical Regulations in China and Hong Kong

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