# One multiregional trial, no bridging studies: enforce ICH E17 in Japan and China

Source: https://onco.cc/ideas/idea-reg-mrct-no-bridging/  
OnCo record `idea-reg-mrct-no-bridging` (Idea). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Idea
- Last checked: 2026-09-08
- 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.
- Proposed 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

## Sources

- ICH efficacy guidelines (E17): https://www.ich.org/page/efficacy-guidelines

## Connected records

- institutions: [National Cancer Center Hospital](https://onco.cc/institutions/ncc-japan/)
- bottlenecks: [Regulatory divergence between regions](https://onco.cc/bottlenecks/b-regulatory-fragmentation/), [Trials do not represent the people who get cancer](https://onco.cc/bottlenecks/b-trial-diversity/)

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