As of January 12th, 2025, Regulation (EU) 2021/2282 on health technology assessment (HTA) officially came into effect, marking a significant milestone in the European Union’s approach to evaluating health technologies. This new legislation aims to streamline and strengthen cooperation among EU Member States, creating a unified framework for assessing a wide range of health technologies, including medicines, medical devices, and other healthcare interventions.
One of the key innovations introduced by the HTA Regulation is the Joint Clinical Assessment (JCA) process, which will focus on the clinical evaluation of new technologies. The JCA will facilitate collaboration among EU countries, reducing duplication of efforts, optimizing resources, and ensuring quicker access to innovative healthcare solutions for patients across the EU.
Key features of the new regulation include:
- Pooling resources at the EU level through a single submission file for joint clinical assessments, which will help streamline the evaluation process.
- Faster procedures designed to provide quicker access to critical medicines for patients in need.
- Patient-centric focus, ensuring that patient perspectives are considered throughout the assessment process.
Initially, these new rules will apply to new cancer medicines and advanced therapy medicinal products (ATMPs). By 2028, they will expand to cover orphan medicines and eventually all new medicinal products entering the market.
At Asphalion, we are ready to assist your company in navigating this new regulatory landscape with expert support tailored to your needs. Whether you’re seeking guidance on compliance or how to optimize your submission strategy, our team is here to help.
Contact us to learn how we can help you successfully navigate these regulatory changes! [email protected]
For more information on the implementation of the HTA Regulation, visit the European Commission’s page here.