Drug Evaluation Committee 2012-05 Validity (Expiration) Labeling of Investigational New Drugs
Related classification: Investigational drugs
Initial Publication Date：2012-06
Revised publication date: Apr. 2024
Question
Please tell me about the labeling of investigational new drug.
Article 16, Paragraph 1, Item 5 of the GCP Ministerial Ordinance states that the container or package of an investigational new drug should be labeled with "details of storage method, expiration date, and other necessary information". What are the items for which it is necessary to specify an expiration date, etc.? Are there any notices, Q&A, etc. that describe this point?
Should we consider it mandatory for new compounds, etc., to indicate the expiration date based on the period during which their stability has been confirmed in stability tests?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
The term "those for which it is necessary to specify the period of validity, etc." as defined in Article 16, Paragraph 1, Item 5 of the GCP Ministerial Ordinance does not uniformly require the indication of the period of validity based on the period for which stability has been confirmed in stability tests, regardless of whether it is a new compound or not.
There is no specific guidance (notification, Q&A, etc.) for "those for which it is necessary to specify the storage method, expiration date, etc." or "those for which it is not necessary to specify the storage method, expiration date, etc.".
However, the sponsor should decide whether or not to specify the possible extensions, such as the expiration date, on the container or package of the investigational drug, taking into consideration the results of stability studies and the duration of the clinical trial using the investigational drug.