Implementation of the New European Health Technology Assessment Regulation (HTAR)

The main challenges in the preparation of the new European Health Technology Assessment Regulation (HTAR) and how ProPharma can help you succeed with your product launch in Europe. 

Initiated in 2021, the European Health Technology Assessment Regulation (HTAR) has ushered in a new era for health technology assessments in Europe. This regulation, a significant change in European market access, aims to unify the perspective among EU member states on clinical aspects of medicinal products development, in vitro diagnostics (IVDs), and high-risk medical devices. The HTAR framework includes Joint Clinical Assessments (JCA), Joint Scientific Consultations (JSC), horizon scanning activities, and voluntary cooperation.

This whitepaper primarily focuses on JCA and JSC, which are essential components for companies planning to submit their Market Authorization Application (MAA) to the European Medicines Agency (EMA). Horizon scanning activities, conducted by the European Commission (EC), are crucial for early identification of emerging health technologies with significant impact potential. Voluntary cooperation involves collaboration in areas like vaccination programs development and national HTA systems capacity building. In addition, the whitepaper discusses:

• HTAR implementation timelines
• When to begin preparing for HTAR
• How to conduct a successful European product launch
• Potential challenges and solutions associated with HTAR compliance 

As the implementation guidelines and requirements for HTAR continue to evolve and change, it can be difficult to keep up with the current status. We have all of the details and information you need in one place. Learn more about HTAR implementation in Europe and how to ensure you are set up for success. Complete our form to get instant access to the whitepaper.