Drug Evaluation Committee 2013-29 Multiple Designation of Investigational Drug Managers
Related classification: Other
First published: Sep. 2013
Revised publication date: December 2021
Question
We have designated "Investigational New Drug Administrator" and "Investigational New Drug Administrative Assistant". As a future policy, we would like to abolish the assistant investigational drug manager and appoint two investigational drug managers, as we believe that there are no special provisions in GCP, etc. regarding the number of investigational drug managers. We would appreciate your opinion on this matter.
JPMA's Opinion
There is no problem in appointing two or more investigational drug managers under the responsibility of the head of the site if it is necessary for the proper management of investigational drugs (GCP Article 39) in accordance with the procedure manual provided by the sponsor. However, since there will be more than one person responsible for the management of investigational drugs, it is desirable to clarify the contact information from the sponsor, investigator, etc. and the scope of management responsibility of both investigational drug managers (if they share the same role).
Reason for revision
Supplementation has been added in accordance with the issuance of the GCP Guidance (August 31, 2020, Pharmaceutical Affairs Council of Japan, No. 0831-15).