Drug Evaluation Committee May 2012: Indication of the Validity Period (Expiration Date) for Investigational New Drugs
Related Category: Investigational Drugs
Initial Publication Date: June 2012
Revised Publication Date: April 2024
Question
Please provide guidance regarding the labeling of
investigational drugs.
Article 16, Paragraph 1, Item 5 of the GCP Ordinance states that the following information must be included on the container or packaging of an investigational drug: “For items requiring the specification of storage methods, shelf life, etc., the details thereof.” What types of items require the specification of shelf life and other such information?Also, what are the items for which it is not necessary to specify such details? Are there any notifications, Q&As, or other documents addressing this point
?
Should we consider it mandatory to indicate the expiration date for new compounds, etc
.
, based on the period during which stability has been confirmed through stability testing?
JPMA Opinion
The phrase “products for which it is necessary to specify the shelf life, etc.” as defined in Article 16, Paragraph 1, Item 5 of the GCP Ordinance does not uniformly require the display of a shelf life based on the period for which stability has been confirmed through stability testing, regardless of whether the product is a new compound or not.
Furthermore, there is no specific guidance (notices, Q&As, etc.) regarding “items for which storage methods, expiration dates, etc., must be specified” or “items for which storage methods, expiration dates, etc., need not be specified.”
Although these items are intended to ensure that investigational drugs are stored and used appropriately, the decision on whether to indicate on the container or packaging of an investigational drug any information that may be subject to extension—such as the shelf life—is left to the judgment of the sponsor, taking into account the results of stability testing and the duration of the clinical trial in which the investigational drug is used.