New scheme related to new drug review and approval

Published:

Recommendations

  • Addition of "Priority review system" and legislation of "Conditional early approval system": According to the promulgation of the Amended Pharmaceuticals and Medical Devices Act on Dec. 4, 2019, “Pioneering drugs” (legislation of "Sakigake designation system"), "Specific use drugs, etc." designation system, and "Conditional early approval system" were implemented  on Sep 1st, 2020. For their operations, preparation of related laws based on the actual state and improvement in the relevant organisational structure and efficient implementation are required.
  • Legislation of (Post Approval Change Management Protocol) system: PACMP system has been established ahead of the application of TECHNICAL AND REGULATORY CONSIDERATIONS FOR PHARMACEUTICAL PRODUCT LIFECYCLE MANAGEMENT (ICH-Q12). After the system will be started on 1st August 2021, we call for a review of relevant laws and regulations to make the system even easier to use based on the situation of the use of the system for a certain period of time.