Swiss Agency Firms Up Role In Multi-Country Drug Review Scheme
New Guidance Explains Workings Of Project Orbis
Experience gained from pilot participation has convinced the Swiss medicines agency that the collaborative cancer drug review initiative is the way forward.
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Promising cancer medicines will need to be included in the UK’s new licensing pathway for innovative drugs before the UK medicines regulator will agree to their review under the Project Orbis initiative.
The new regulation on cross-border threats to health is the final part of the European Health Union, along with strengthened roles for the European Medicines Agency and the European Centre for Disease Prevention and Control. Its aim is to ensure collective EU action on preparedness, surveillance, risk assessment, and early warning and response in the event of health emergencies.
Experiences during the COVID-19 pandemic are expected to help identify future opportunities for regulatory cooperation on real-world evidence and avoid divergent decision-making for products including advanced therapies and personalized medicines.