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 company name and location of the sponsor has changed. A letter informing each medical institution of the change in company name and location has been provided. 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 implementing medical institution 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 we will over-label the old company name and address with the new 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.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
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 the site, the sponsor's staff (e.g., monitors) should change the labeling in accordance with the procedures in compliance with investigational drug GMP.
In addition, since the change of the sponsor's company name and address is not considered to affect appropriate quality control of the investigational new drug, it is acceptable to provide a document indicating the change to the site and store it with the investigational new drug.