Drug Evaluation Committee 2018-61 Change of Investigational New Drug Label due to Change of Company Name and Location
Related classification: Investigational drugs
Date of first publication: 2019-04
Question
The name and address of the sponsor has changed. H-row has provided each medical institution with a letter informing them of the change in company name and location. The investigational drug will be used only for inpatients and will not be taken home by subjects. In addition, some of the investigational drug has already been delivered to the Investigator Site and is stored in our warehouse.
In this case, is it necessary to change the company name on the investigational drug label? Is it sufficient to change the company name and location? If we must change the label, is it sufficient to change only the portion stored in our warehouse? (We are assuming that the new company name and address should be over-labeled on the old company name and address only.)
When changing the company name (over-labeling) of the investigational new drug label, is it sufficient to do the work under non-GMP control? In other words, is there a problem if the procedure is completed in the clinical department without GMP staff involvement, from the creation of the procedure to the implementation of the work? What are the minimum steps that need to be taken when changing the company name (over-labeling) of the investigational new drug label?
In the past, there was a question about when the "company name" is changed, but please tell us if it is acceptable to change the company name and address when the "location" is also changed.
JPMA's Opinion
As stated in GCP Article 1 Guidance 2 (12), the manufacture, handling, storage and management of investigational new drugs must be conducted in compliance with investigational new drug GMP. Therefore, changes in the labeling of investigational new drug must be made in accordance with investigational new drug GMP. For investigational drugs that have already been delivered to Investigator Site, the sponsor's staff (e.g., monitors) should change the labeling in accordance with the procedures in compliance with investigational drug GMP.
Since the change of the sponsor's company name and address is not considered to affect appropriate quality control of the investigational drug, it is acceptable to provide the Investigator Site with a document indicating the change and to keep the document with the investigational drug.