{"entity":{"id":"idea-reg-joint-scientific-advice-default","kind":"idea","name":"Joint FDA-EMA-MHRA-PMDA scientific advice by default before pivotal cancer trials","aka":[],"tldr":"Before a company runs its phase 3 cancer trial, FDA, EMA, MHRA, PMDA, Health Canada and TGA would agree the endpoints, comparator, population and statistical plan in one joint written advice letter, so a single trial can support approval everywhere. Today parallel advice is used for a handful of products a year.","summary":"FDA-EMA parallel scientific advice exists but is used for a handful of products a year. The proposal is to make a joint written advice procedure covering endpoints, comparator, population and statistical plan the default for phase 3 oncology programmes, with PMDA, MHRA, Health Canada and TGA as standing participants. Advice would be recorded as a single agreed letter identifying any residual divergence, and divergence would be published in aggregate.","asOf":"2026-09-08","links":[{"label":"EMA-FDA parallel scientific advice (page moved; nearest live section)","url":"https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-advice-protocol-assistance/"}],"tags":[],"related":[],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":["b-regulatory-fragmentation","b-trial-design"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"hypothesis":"Programmes with joint advice require fewer region-specific supplementary trials and reach approval in a second region a median of six months sooner than programmes with sequential single-agency advice.","rationale":"Most regional divergence in oncology approvals traces to disagreements over comparator, endpoint (PFS versus OS) or population fixed years earlier at design. Resolving them once, early, is cheaper than reconciling them at filing.","test":"Retrospectively compare approval divergence for products that used parallel advice with matched products that did not; then prospectively offer joint advice to all phase 3 oncology programmes for two years and track the same measures.","maturity":"early-clinical","actor":"regulator","cost":"small","horizonYears":3},"route":"/ideas/idea-reg-joint-scientific-advice-default/","neighbours":{"bottleneck":[{"id":"b-regulatory-fragmentation","kind":"bottleneck","name":"Regulatory divergence between regions","route":"/bottlenecks/b-regulatory-fragmentation/"},{"id":"b-trial-design","kind":"bottleneck","name":"Trial design, endpoints and cost","route":"/bottlenecks/b-trial-design/"}]}}