Drug Evaluation Committee 2018-34 Methods of Expedited Review
Related classification: Clinical Trial Review Committee
Date first published: December 2018
Question
As GCP guidance, "The conditions for expedited review and approval (scope of application of expedited review, who makes the decision, review method, report to the next meeting of the Clinical Trial Review Committee, etc.) shall be established for minor changes related to an ongoing clinical trial that has already been approved by the Clinical Trial Review Committee." This is stated in the GCP.
Although not GCP, the following response was provided in an Office Communication "Q&A on Enforcement of the Clinical Research Act (Part 5)" dated October 16, 2008, from the Research and Development Promotion Division, Medical Affairs Bureau, Ministry of Health, Labour and Welfare, regarding the Clinical Research Act. This office communication is an approach to "expedited review, etc." by the Authorized Clinical Research Review Committee for the implementation of clinical research subject to the Clinical Research Act.
Excerpt from Q&A on the Enforcement of the Clinical Research Act (Part 5)
Q70
Of the items for which review and opinion services can be performed by the method (simplified review, etc.) stipulated in the operational rules based on Article 80, Paragraph 4 of the Regulations, those items for which the chair recognizes that prior confirmation is not necessary can be handled by the secretariat of the accreditation committee by specifically stipulating in the operational rules in advance as items for which prior confirmation is not required. (For example, as a specific administrative procedure, the principal investigator shall submit to the secretariat a written request for review of changes to the implementation plan, clearly stating that the changes fall under only the matters that do not require prior confirmation, The secretariat is supposed to confirm that the change falls under the items that do not require prior confirmation, stamp the request for review with a seal of acceptance, and issue a copy of the request for review, and deem the change to have been approved only by the procedure of acceptance).
Answer
It is not required.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Article 28, Paragraph 2, Guidance 2 (3) and (4) of the GCP requires that the conditions for expedited review and its approval (scope of application of expedited review, who makes decisions, review method, report to the next meeting of the investigational review committee, etc.) be stipulated in the protocol of the investigational review committee, but specific procedures related to expedited review are not specified. However, specific procedures for expedited review are not specified. Therefore, the method of expedited review should be decided according to the current status of each review committee.
There are some differences in review items and materials to be reviewed between GCP-based Clinical Trial Review Committees and the Clinical Research Law-based Authorized Clinical Research Review Committees. Therefore, we are not sure if the concept of "expedited review, etc." under the Clinical Research Act can be applied to all GCP.