Drug Evaluation Committee 2009-06 Form for Six-Monthly Accumulation of Safety Information for Investigational Drugs to be Provided to Investigator Sites
Related classification: Clinical trial contract procedures
First published: Jul 2009
Question
A sponsor has asked us to submit the safety information and the 6-monthly accumulation itself as a separate volume of the investigational new drug summary. They have decided to use "Investigational New Drug Summary Supplement, Version XX" as an attachment to the new safety information report. Please tell me whether it is appropriate to take this kind of action and whether it is more common for sponsors to do the same.
JPMA's Opinion
If the sponsor's protocol stipulates that the document for notifying Investigator Site of adverse drug reactions should be a separate volume of the investigational new drug summary, there is no problem in responding to your question.
In "Partial Revision of 'Postmarketing Adverse Reaction Reports and Adverse Reaction Reports for Clinical Trials'" (NHI Drugs and Foods Review No. 1001009 and NHI Drug Safety Report No. 100001, dated October 1, 2008), the criteria for determining the predictability of adverse reactions are stated as "The date of "predictable" should be the date the investigational drug summary is prepared or revised. However, the date of "predictable" should be the date of preparation or revision of the investigational new drug summary. However, if the sponsor's protocol stipulates that a document notifying the Investigator Site of adverse drug reactions should be kept as a separate volume of the investigational new drug summary, the date of creation of the notification document may be considered the date of revision of the investigational new drug summary. The new regulation stipulates that "the date of the preparation of the notification document shall be considered as the date of revision of the investigational new drug summary.
The way in which new safety information on the investigational drug and information accumulated every six months should be included in the investigational drug summary depends on the judgment of the sponsor, so we cannot say whether the response to your question is general or not.
Reason for revision
The "Points to be Noted Concerning the Enforcement of the Ministerial Ordinance Partially Amending the Ordinance for Enforcement of the Pharmaceutical Affairs Law" (Pharmaceutical Affairs Ministry Ordinance No. 1228/11, dated December 28, 2012) states, "The notification from the sponsor to the investigator and the head of the Investigator Site pursuant to Article 20, Paragraph 2 of the GCP shall be made within three months after the expiration of the investigational unit period. "The sponsor shall notify the investigator and the head of the site of the latest clinical trial safety report and a list of the occurrence of serious adverse drug reactions in Japan within three months after the expiration of the investigational unit period by attaching the attached reference form "Annual Report on Clinical Trial Safety Information". The notification is attached to the attached reference form "Annual Report of Clinical Trial Safety Information".
Therefore, it is necessary to respond to the notification of the safety information in accordance with this notice.