Loading
Japan and China have often required extra local studies before accepting a global trial. Committing to accept well-designed global trials would bring drugs to Asian patients years earlier.
ICH E17 (2017) describes how a multiregional clinical trial can support approval in all participating regions. In practice, sponsors still run bridging or local phase 1 studies for Japan and China, and China's requirement for local data has only partly relaxed. The proposal is a formal commitment by PMDA and NMPA, monitored through ICH, that MRCTs meeting E17 criteria (pre-specified regional enrolment, consistency assessment) remove the need for bridging studies, with a published list of exceptions.
Shares Trials do not represent the people who get cancer, Regulatory divergence between regions.
Shares National Cancer Center Hospital, Regulatory divergence between regions.
Shares National Cancer Center Hospital, Regulatory divergence between regions.
Shares National Cancer Center Hospital, Regulatory divergence between regions.
Shares Trials do not represent the people who get cancer, Regulatory divergence between regions.
Shares Trials do not represent the people who get cancer, Regulatory divergence between regions.
Shares Trials do not represent the people who get cancer, Regulatory divergence between regions.
Shares Trials do not represent the people who get cancer, Regulatory divergence between regions.