Drug Evaluation Committee June 2013: How to Record the Expiration Date of Investigational New Drugs on the Investigational New Drug Management Form
Related Category: Investigational Drugs
Initial Publication Date: July 2013
Revised Publication Date: April 2024
Question
The Guidance on Article 39 of GCP stipulates that the “expiration date of the investigational drug (if applicable)” must be included in the Investigational Drug Management Sheet. How should this be interpreted?
For trials where the expiration date is frequently extended, I would like to ask whether it is permissible to include the notation “*See the Investigational Drug Management Procedure for the expiration date” in the Investigational Drug Management Record and file the successively revised Investigational Drug Management Procedure within the same file.Also, what circumstances does “when necessary” refer to in the phrase “expiration date of the investigational drug (when necessary)”?
JPMA Opinion
The Investigational Drug Management Record is a document that records that the investigational drug was managed and appropriately administered to subjects in accordance with the “Procedures for the Management of Investigational Drugs” provided by the sponsor.Regarding the “expiration date of the investigational drug” mentioned in your question, it is presumed that the sponsor has determined the necessity of labeling the container or packaging of the investigational drug in accordance with Article 16, Paragraph 1 of GCP; therefore, we recommend confirming this with the sponsor, including how it should be recorded in the Investigational Drug Management Record.
Please refer to past Opinion
No. 2012-05 regarding the circumstances under which the “expiration date of the investigational drug (if required)” is necessary.