Drug Evaluation Committee 2009-01 Transfer of Investigational New Drugs between Medical Institutions
Related classification: Other
First published: Jul. 2009
Question
Background
As an exceptional measure to ensure a reliable supply of investigational drugs in global clinical trials, a procedure has been established for transferring investigational drugs from one site to another. In doing so, "the history of the investigational drug at the site is evaluated to confirm the appropriateness of the investigational drug to be transferred. This includes a review of monitoring reports and records of storage conditions at the originating site, as well as a check of the physical integrity of the investigational drug." and that the investigational drug was properly stored.
Question
If the appropriateness of the investigational drug is confirmed, we do not think there is any problem with using it at another site. In that case, is there any problem under GCP if the sponsor does not collect the investigational drug once and then deliver it to another site, but transfers it from one site to another? There are various possible methods of transfer, such as the monitor collecting the investigational new drug and delivering it to another site, or outsourcing the transportation of the investigational new drug. We would appreciate it if you could enlighten us.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Article 16, paragraph 4 of the GCP stipulates that "The sponsor must package the investigational drug and deliver it to the site to prevent contamination or deterioration during transport and storage." Article 17 of the GCP stipulates that "the sponsor must deliver the investigational new drug to the site. Article 17 of the GCP also stipulates that "The sponsor shall deliver to the site under the sponsor's responsibility an investigational new drug manufactured at a manufacturing facility equipped with the necessary structural facilities to ensure the quality of the investigational new drug and with appropriate manufacturing and quality control methods. The provision also stipulates that "the sponsor is responsible for the delivery of the investigational new drug to the site of the clinical trial. Therefore, the sponsor is basically required to deliver the investigational drug manufactured at the manufacturing site and properly quality-controlled to the site, so even in the exceptional case of transferring an investigational drug once delivered to a site to another site, the sponsor must be responsible for the transfer. The sponsor must be responsible for the transfer.
It depends on the content of the sponsor's protocol, but if a qualified person on the sponsor's side is able to "evaluate the history of the investigational drug at the site" (check the appropriateness of the investigational drug to be transferred) at the site where the investigational drug is stored, then it should be possible to transfer the investigational drug from that site to another site. If the investigational new drug can be transferred from one site to another, it should be possible to transfer the investigational new drug to another site. However, in such cases, it is necessary to take necessary measures such as preparing a procedure manual for ensuring quality control, transport and delivery, and concluding a contract with the relevant carrier, etc. (Guidance 5, Article 17 of GCP). (Guidance 5, Article 17 of GCP).
The "evaluation of the history of the investigational drug at the site" is a matter for the sponsor to determine according to the characteristics of the investigational drug, but it should be done in cooperation with the site and sufficient evidence should be left behind.