Drug Evaluation Committee 2014-51 Provision of Safety Information from the Sponsor to the Clinical Trial Review Committee
Related classification: clinical trial contracting procedures
First published: Apr 2015
Revised publication date: Mar 2021
Question
With regard to the direct notification of safety information by a sponsor to the Clinical Trial Review Committee, the action report and research report under Article 273, Paragraph 2, Item 2 (c) and (ii) of the Enforcement Regulations of the Pharmaceutical Affairs Law (Pharmaceuticals and Medical Devices Law) are defined in the operational notice regarding direct notification to the Clinical Trial Review Committee in the GCP Guidance as "Notification regarding Article 20, Paragraph 2 and 3 The notification may be made at the same time." The GCP Guidance on Direct Notification to the Clinical Trial Review Committee does not apply to the "Notification to the Clinical Trial Review Committee may be made at the same time. Are action reports and research reports not subject to direct notification from the sponsor to the investigational review committee?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
As you understand, at the end of GCP Article 20, Paragraph 2/3, Guidance 3, it states "The scope and handling of adverse reactions to be notified shall be in accordance with the provisions of Article 273, Paragraphs 1 and 2 of the Enforcement Regulations". Therefore, in accordance with Article 20, Paragraph 2/3, Guidance 4 of the GCP, it is acceptable to directly notify these safety information to the Clinical Trial Review Committee. The sponsor must immediately notify the investigator and the head of the site of the action taken and the research report, and the investigational review committee must also be notified at the same time.
Reason for revision of opinion
With the issuance of the GCP Guidance (No. 0831-15 issued on August 31, 2020 by the Pharmaceutical Affairs Agency of Japan), minor changes have been made to the descriptions.