Drug Evaluation Committee 2014-51 Provision of Safety Information from the Sponsor to the Clinical Trial Review Committee
Related classification: Clinical trial contract 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, Items 2(c) and 2(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 of the GCP Guidance as "Notification regarding Article 20, Paragraph 2 and Paragraph 3 of the 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 only with respect to Article 20, Paragraphs 2 and 3". Are action reports and research reports not subject to direct notification from the sponsor to the investigational review committee?
JPMA's Opinion
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 is to immediately notify the investigator and the head of the institution of the clinical trial of the action report and the research report, which must also be notified to the Clinical Trial Review Committee at the same time.
Reason for revision
We have made minor changes to the descriptions in accordance with the issuance of GCP Guidance (August 31, 2020, Pharmaceutical Affairs Council of Japan, No. 0831-15).