Regulatory and operational challenges in conducting Asian International Academic Trial for expanding the indications of cancer drugs.

ABSTRACT: There are many differences between Asian regions in terms of the regulatory requirements and operational procedures in conducting international academic clinical trials for the approval of new drugs. The National Cancer Center Hospital in Japan has launched an international investigator-initiated registration-directed trial (IIRDT) in Japan, Korea, Taiwan, and Singapore, aiming at obtaining pharmaceutical approval in participating regions. Differences in regulatory and operational procedures were identified while coordinating the trial. In Japan, regulatory authority reviews should be performed after approval by institutional review boards for IIRDT, whereas in other regions these can be done in parallel. There were disparities in Good Manufacturing Practice-related documents between regio

SUBMITTER: Hata T 

PROVIDER: S-EPMC8212724 | biostudies-literature | 2021 May

REPOSITORIES: biostudies-literature