{"entity":{"id":"idea-reg-mrct-no-bridging","kind":"idea","name":"One multiregional trial, no bridging studies: enforce ICH E17 in Japan and China","aka":[],"tldr":"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.","summary":"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.","asOf":"2026-09-08","links":[{"label":"ICH efficacy guidelines (E17)","url":"https://www.ich.org/page/efficacy-guidelines"}],"tags":[],"related":[],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":["ncc-japan"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":["b-regulatory-fragmentation","b-trial-diversity"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"hypothesis":"The 'drug lag' between US and Japanese or Chinese oncology approvals falls below six months for products developed under E17-compliant MRCTs, compared with a historical lag of two to four years.","rationale":"Ethnic sensitivity for most modern targeted and immune therapies is small and can be assessed within an MRCT; bridging studies delay access without changing decisions in most cases. PMDA's 2024 relaxation of the Japanese phase 1 requirement for many drugs shows movement is possible.","test":"Audit the last 50 oncology approvals in Japan and China for bridging requirements and approval lag; pilot E17 commitments for the next 20 oncology MRCTs with pre-specified regional enrolment.","maturity":"early-clinical","actor":"regulator","cost":"small","horizonYears":3},"route":"/ideas/idea-reg-mrct-no-bridging/","neighbours":{"institution":[{"id":"ncc-japan","kind":"institution","name":"National Cancer Center Hospital","route":"/institutions/ncc-japan/"}],"bottleneck":[{"id":"b-regulatory-fragmentation","kind":"bottleneck","name":"Regulatory divergence between regions","route":"/bottlenecks/b-regulatory-fragmentation/"},{"id":"b-trial-diversity","kind":"bottleneck","name":"Trials do not represent the people who get cancer","route":"/bottlenecks/b-trial-diversity/"}]}}