White Paper: Global Expedited Review Programs & Incentives
Published June 2021
Abstract:
Expedited review programs have been developed by regulatory authorities to help expedite and support drug development and review. These programs are intended to help ensure that therapies are approved and available to patients as early as possible while ensuring that the therapies’ benefits justify their risks. This white paper covers:
- What is an Expedited Review Program?
- Swiss Medic's Expedited Review Program
- EMA's Expedited Review Program
- TGA's Expedited Review Program
- Orphan Drug Programs
Keywords: Health Canada, priority review, NOC/c, FDA, fast track, accelerated approval, breakthrough therapy, SwizzMedic, PRIME, conditional approval, accelerated assessment, compassionate use, exceptional circumstances, provisional approval, orphan drug, market exclusivity, global regulations
Click here to view White paper: Global Expedited Review Programs & Incentives