Asian Journal Of Social Pharmacy

Abstract: Objective To provide references for reforming new drug review procedures in China. Methods Relevant principles and literatures on drug registration management were studied to analyze new drug review procedures and openness in the United States. Some experiences were learned for optimizing new drug approval system in China, combined with the newly issued the State Council’s Opinion on the Reform of the System for Drug and Medical Device Evaluation and Approval. Results and Conclusion It will contribute to improving drug review and approval system and promoting new drugs research and development in China by learning the experiences of U.S. on new drug review and approval procedure and openness, such as optimizing the clinical administration, application procedure and review on division of labor; changing the constitution of drug review committee and releasing the drug review report, etc.

Key words: China, U.S., drug review