Drug Evaluation Committee 2013-06 How to enter expiry date of investigational new drug in the investigational new drug control chart
Related classification: Investigational drugs
Initial release date: Jul 2013
Revised publication date: Apr 2024
Question
One of the items that must be included in the investigational new drug control chart, as stipulated in GCP Article 39 Guidance, is "Expiration date of the investigational new drug (if necessary).
I would like to ask if it is possible, in the case of a study with frequent expiration date extensions, to use "*Refer to the investigational new drug management protocol for expiration date" in the investigational new drug management chart and file the sequentially revised investigational new drug management protocol in the same file. Also, what do you mean by "expiration date of investigational new drug (when necessary)" when it is necessary?
Pharmaceutical Association's Opinion
An investigational drug control chart is a document that records that the investigational drug was controlled and used appropriately for the subject in accordance with the "Protocol for the Control of Investigational Drugs" provided by the sponsor. Regarding the "expiration date" of the investigational drug in question, we believe that the sponsor determines the necessity of labeling on the container or package of the investigational drug in accordance with Article 16-1 of the GCP.
Please refer to the previous Opinion 2012-05 regarding when the "Expiration date of investigational new drug (if necessary)" is necessary.