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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.
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.
Shares NTRK, RET, Tumour-agnostic (tissue-agnostic) approval, Regulatory divergence between regions.
Shares NTRK, RET, Tumour-agnostic (tissue-agnostic) approval, Regulatory divergence between regions.
Shares Regulatory divergence between regions, Most of the world has almost no cancer care.
Shares Accelerated approval, Regulatory divergence between regions.
Shares Regulatory divergence between regions, Most of the world has almost no cancer care.
Shares Accelerated approval, Regulatory divergence between regions.
Shares Accelerated approval, Regulatory divergence between regions.
Shares Regulatory divergence between regions, Most of the world has almost no cancer care.