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Regulators in several countries already look at the same cancer drug dossier at the same time. Let them split the work and write one report instead of six.
Project Orbis (FDA Oncology Center of Excellence, with Australia, Canada, UK, Switzerland, Singapore, Brazil, Israel) coordinates concurrent review but each agency still writes its own full assessment. The proposal is formal work-sharing: one agency leads clinical, another CMC, another statistics, producing a single shared assessment report that each partner adopts with a short national addendum. The Access Consortium already work-shares among smaller agencies; extending the model to Orbis would remove most duplicated review effort.
Shares FDA Oncology Approvals (OCE) & Novel Drug Approvals, Trial modernisation roadmap: the randomised trial → platforms and adaptive designs → decentralised, pragmatic and always-on, Regulatory divergence between regions.
Shares FDA Oncology Approvals (OCE) & Novel Drug Approvals, Regulatory divergence between regions.
Shares FDA Oncology Approvals (OCE) & Novel Drug Approvals, Regulatory divergence between regions.
Shares FDA Oncology Approvals (OCE) & Novel Drug Approvals, Trial modernisation roadmap: the randomised trial → platforms and adaptive designs → decentralised, pragmatic and always-on.
Shares FDA Oncology Approvals (OCE) & Novel Drug Approvals, Regulatory divergence between regions.
Shares Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation, Regulatory divergence between regions.
Shares Trial modernisation roadmap: the randomised trial → platforms and adaptive designs → decentralised, pragmatic and always-on, Regulatory divergence between regions.
Shares Trial modernisation roadmap: the randomised trial → platforms and adaptive designs → decentralised, pragmatic and always-on, Regulatory divergence between regions.