Turn Project Orbis into a work-sharing review with one shared assessment report
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.
- Regulatory divergence between regions · Regulatory divergence means a drug approved in one country can take years to reach another, or never arrive.
Pages like this
not linked directly; found by shared links- IdeaA public index of how the same cancer drug's label differs between countries
Shares FDA Oncology Approvals (OCE) & Novel Drug Approvals, Regulatory divergence between regions.
- IdeaPublish every complete response letter and negative opinion across all regulators
Shares FDA Oncology Approvals (OCE) & Novel Drug Approvals, Regulatory divergence between regions.
- IdeaLive tracker of the lag from first approval to real availability in every country
Shares FDA Oncology Approvals (OCE) & Novel Drug Approvals, Regulatory divergence between regions.
- IdeaConditional approvals that lapse automatically if the confirmatory trial is late
Shares FDA Oncology Approvals (OCE) & Novel Drug Approvals, Regulatory divergence between regions.
- InstitutionFDA Oncology Center of Excellence
Shares FDA Oncology Approvals (OCE) & Novel Drug Approvals, Regulatory divergence between regions.