Drug Evaluation Committee 2010-30 Notification to medical institutions regarding expiration of record retention period

Related classification: Record keeping

First published: October 2010
Revised publication date: March 2021

Question

Background

GCP Article 4, Paragraph 1 Guidance 6 stipulates that the sponsor shall notify the site where the clinical trial is conducted (hereinafter referred to as "site") of the fact when the manufacturing and marketing approval is obtained and when the retention of documents related to the clinical trial (hereinafter referred to as "documents, etc.") is no longer required.

Considering GCP Article 34 Paragraph 1 Guidance 1 and Article 41 Paragraph 2 Guidance 1, if the manufacturing and marketing approval date is earlier than the date on which three years have passed since the discontinuation or termination of the clinical trial, the sponsor may need to notify the following two times.

Question 1

In the "Report on Obtaining Manufacturing and Marketing Approval, Discontinuation of Development, etc.," Notice 1 also includes the following statement: "Please handle the clinical trial materials currently stored at your medical institution as follows. Please retain them until the date of XXXXXXXXXXXXXXXXXXXX." Since "Notice 1" states the retention period of the documents, etc., it seems possible that "Notice 1" could be interpreted as doubling as "Notice 2" (Notice 2 is unnecessary).

Question 2

In particular, we question the necessity of Notice 2 when the period between the date of marketing approval and the date three years have elapsed since the discontinuation or termination of the clinical trial is as short as a few months, for example. If the answer to Question 1 is that "Notification 2 is necessary," it may be acceptable to limit this period, e.g., to stipulate in an internal rule that "If the period between the marketing approval date and the date three years have passed since the discontinuation or termination of the clinical trial is less than three months, the Notification 1 may also serve as Notification 2 by specifying the retention period of documents, etc. in the Notification. Would it be in conflict with GCP?

Question 3

Similarly, at the time of discontinuation of development, we think it would be possible to interpret that "Notice 1 of discontinuation of development also serves as Notice 2 that does not require retention of documents after 3 years from the date of notification of the decision to discontinue development (Notice 2 is not required)".

Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)

As stated in your question, the sponsor is required to notify to that effect (GCP Article 4, Paragraph 1, Guidance 6(4)) upon obtaining manufacturing and marketing approval, etc., and when the records to be preserved by the site and the investigational review committee are no longer required to be preserved (GCP Article 4, Paragraph 1, Guidance 6). The site is required to notify the investigational sites of this fact (GCP Article 4.1 Guidance 6).

The site is to handle the records to be preserved in accordance with the information provided by the sponsor. For this purpose, it is important that the sponsor appropriately notifies the investigator of this information, and there is no problem with the method of notification, whether individually or in combination.

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.

Back to Clinical Trial 119 Top

TOP