The New European Pharmaceutical Landscape: What You Need to Know When Launching in the EU
1:00 PM - 2:00 PM (EDT), Monday, June 5, 2023 ・ Session Room 209
The EU pharmaceutical landscape is experiencing its most significant transformation in over 20 years and signals a fundamental shift in thinking. The EU Is revising the regulatory and incentive systems for all medicines, including orphan products. The imminent application of the EU HTA Procedure means there will be a new mandatory system for assessing the clinical value of new products for the European market, starting with cancer therapies and Advanced Therapy Medicinal Products (ATMPs) in 2025, Orphan drugs will come into effect in 2028 and all products approved by the EMA will follow in 2030. The full EU pharmaceutical ecosystem is being updated in the coming decade and this session will explore the essentials you need to consider before launching your product in the EU.