亚洲社会药学
亚洲社会药学

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亚洲社会药学 ›› 2016, Vol. 11 ›› Issue (1): 19-24.

• 论文 • 上一篇    下一篇

U.S. and China: New Drug Review Procedures and Openness

Han Yueyuan1, 2, Tian Lijuan1*   

  1. 1.School of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China; 2.Taiho Pharmaceutical of Beijing Co., Ltd., Beijing 100004, China
  • 出版日期:2016-01-07 发布日期:2016-01-07
  • 通讯作者: Tian Lijuan, associate professor. Major research areas: drug policy, pharmacy administration and regulation, rational drug use. Tel: 15840095857, E-mail: tianlijuan_8@126.com

U.S. and China: New Drug Review Procedures and Openness

Han Yueyuan1, 2, Tian Lijuan1*   

  1. 1.School of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China; 2.Taiho Pharmaceutical of Beijing Co., Ltd., Beijing 100004, China
  • Online:2016-01-07 Published:2016-01-07
  • Contact: Tian Lijuan, associate professor. Major research areas: drug policy, pharmacy administration and regulation, rational drug use. Tel: 15840095857, E-mail: tianlijuan_8@126.com

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摘要： 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.

关键词: China, U.S., drug review

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

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