Abstract
Clinical research is a very broad area. This paper shall limit its discussion on clinical research to pharmaceutical development, particularly in new drug development which seeks a regulatory agency's approval. The application procedures, document requirements, and clinical trial centers designated by the Ministry of Public Health (MOPH), qualified clinical investigators, and Good Clinical Practice (GCP) shall be discussed. The existing problems in clinical trials will also be addressed. Finally, the author offers his recommendations (for government, academia, and industry) and perceived outlook on clinical research in the early 21st century in China.
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