Drug Evaluation Committee 2020-43 Request on behalf of the National Supervisor for Clinical Trials
Related classification: Other
First published: Feb. 2021
Question
When an overseas pharmaceutical company that does not have a base in Japan conducts a clinical trial, it can request an in-country clinical trial manager (mainly belonging to a CRO) to perform the clinical trial work on its behalf.
JPMA's Opinion
For those who wish to request a clinical trial that does not have an address in Japan, it is possible to appoint a pharmaceutical company with a base (office, etc.) in Japan (or an overseas pharmaceutical company that has a Japanese corporation as a group company) as a domestic manager of the clinical trial, even if the company does not have its office in Japan.