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Measures to Speed up Drug Review Process in Japan and Its Implications

Shi Wenwen, Sun Lihua*   

  1. School?of?Business?Administration,?Shenyang?Pharmaceutical?University,?Shenyang?110016,?China
  • 出版日期:2017-06-20 发布日期:2017-08-31

Measures to Speed up Drug Review Process in Japan and Its Implications

Shi Wenwen, Sun Lihua*   

  1. School?of?Business?Administration,?Shenyang?Pharmaceutical?University,?Shenyang?110016,?China
  • Online:2017-06-20 Published:2017-08-31
  • Contact: Sun Lihua, professor. Major research area: pharmacoeconomics, medical investment performance and management, etc. Tel: 024-23986553, E-mail: slh-3632@163.com.

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摘要： Objective To provide references for improving the efficiency of drug review process in China. Methods systematical analysis was conducted to study the background, measures and achievements of drug review in Japan. Results and Conclusion Japan managed to change the situation of “lag of drug listing” by increasing the number of working staffs, enhancing review training, optimizing review procedures, strengthening the management of electronic submission data and review process, and expanding the range of communication significantly. By the end of 2014, the standard review time had been reduced to 11.9 months, and priority review time had been reduced to 8.8 months. Therefore, the development and evaluation of innovative drugs can be accelerated by means of preevaluation, increasing the numbers of the working staffs. Besides, a detailed review schedule should be set up and the supervision of the review process must be strengthened so that review department has to abide by the strict time limit. The communication of review should be standardized and the communication quality and the review efficiency should be improved.

关键词: drug review, clinical trial consultation, review time

Abstract: Objective To provide references for improving the efficiency of drug review process in China. Methods systematical analysis was conducted to study the background, measures and achievements of drug review in Japan. Results and Conclusion Japan managed to change the situation of “lag of drug listing” by increasing the number of working staffs, enhancing review training, optimizing review procedures, strengthening the management of electronic submission data and review process, and expanding the range of communication significantly. By the end of 2014, the standard review time had been reduced to 11.9 months, and priority review time had been reduced to 8.8 months. Therefore, the development and evaluation of innovative drugs can be accelerated by means of preevaluation, increasing the numbers of the working staffs. Besides, a detailed review schedule should be set up and the supervision of the review process must be strengthened so that review department has to abide by the strict time limit. The communication of review should be standardized and the communication quality and the review efficiency should be improved.

Key words: drug review, clinical trial consultation, review time

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