# Reciprocal recognition of tumour-agnostic and rare-indication approvals across regulators

Source: https://onco.cc/ideas/idea-moon-reciprocal-tumour-agnostic-approvals/  
OnCo record `idea-moon-reciprocal-tumour-agnostic-approvals` (Idea). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

When a trusted regulator approves a cancer drug for a rare genetic target, other countries should recognise that approval within months instead of repeating years of review.

## Summary

Tumour-agnostic and biomarker-defined rare indications (NTRK fusions, MSI-high, RET, BRAF V600E) are approved at different times in different regions, and many countries never review them at all, leaving patients without access. Reliance pathways (Project Orbis, Access Consortium, WHO collaborative registration) show regulatory reliance works. The proposal is a formal reciprocal recognition agreement for defined categories, with automatic provisional authorisation in participating countries within 90 days of a reference approval, shared post-marketing obligations, and pricing negotiated in parallel.

## Fields

- Kind: Idea
- Last checked: 2026-09-08
- Hypothesis: Reciprocal recognition cuts the median gap between first and subsequent approvals for these indications from years to under six months and increases the number of countries with access severalfold.
- Rationale: Duplicate review adds delay and cost without adding safety for indications with identical evidence; reliance is already accepted policy for vaccines and generics in many jurisdictions.
- Proposed test: Agreement among five regulators for tumour-agnostic indications; measure time to authorisation and access before and after.
- Maturity: early-clinical
- Actor: regulator

## Sources

- Bottleneck evidence (Regulatory divergence between regions): FDA Oncology Center of Excellence, Project Orbis: https://www.fda.gov/about-fda/oncology-center-excellence/project-orbis

## Connected records

- targets: [BRAF](https://onco.cc/targets/braf/), [NTRK](https://onco.cc/targets/ntrk/), [RET](https://onco.cc/targets/ret/)
- terms: [Accelerated approval](https://onco.cc/terms/accelerated-approval/), [Tumour-agnostic (tissue-agnostic) approval](https://onco.cc/terms/tumour-agnostic/)
- bottlenecks: [Most of the world has almost no cancer care](https://onco.cc/bottlenecks/b-global-access/), [Regulatory divergence between regions](https://onco.cc/bottlenecks/b-regulatory-fragmentation/)

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