Drug Evaluation Committee 2018-64 Time of additional delivery of investigational new drug at the time of change of sponsor
Related classification: Investigational drugs
Date of first publication: 2019-04
Question
The sponsor of a clinical trial for which subjects are being enrolled has suddenly changed. We are currently in the process of changing the sponsor and have not yet signed a contract with the new sponsor, but the clinical trial is still ongoing and we are able to enroll subjects.
We are planning to have a new investigational new drug brought in as the investigational new drug is about to expire. We were informed that the label name of the lot of the investigational drug to be brought in has the name of the new sponsor on it, instead of the name of the current sponsor. Since there are no subjects undergoing treatment with the investigational drug, we are considering temporarily suspending the registration and bringing in the investigational drug after the contract with the new sponsor is completed.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
We believe that in principle, investigational new drugs with the name of the new sponsor should be received at the site after the conclusion of the contract with the new sponsor.
However, if the current sponsor and the new sponsor have agreed that the new sponsor will succeed to the contract with your hospital, and your hospital has also agreed to proceed with the procedures to change the contractor of the current contract, the prohibition of prior delivery of investigational new drug stipulated in Article 11 of the GCP would not apply. Therefore, we believe that it is acceptable for the investigational new drug to be delivered prior to the conclusion of the contract with the new sponsor.