Joint Scientific Consultation in the new EU HTA Regulation
With the new EU Health Technology Assessment (HTA) Regulation, significant changes are effective for Health Technology Developers (HTDs). One of the critical components of this new regulation is the Joint Scientific Consultation (JSC), a collaborative framework between HTDs and EU HTA bodies (HTAb) designed to streamline and enhance the clinical development of medicinal products and […]
Understanding Joint Clinical Assessment (JCA)
The evolving landscape of health technology assessment (HTA) in the European Union (EU) is characterised by a significant development: the introduction of joint clinical assessments (JCA) in 2025. This initiative, part of the new HTA regulation, aims to enhance efficiency, improve the quality of evaluations, and ultimately ensure that patients gain quicker access to innovative […]
Introduction to EU Health Technology Assessment Regulation (HTAR)
On the 12th of January 2025, the new EU Health Technology Assessment (HTA) Regulation (EU-HTAR) became effective. With the introduction of the EU-HTAR, pharmaceutical companies engaged in clinical trials have entered a new era of requirements and planning. This regulation aims to harmonise and streamline the assessment processes for health technologies across EU member states, […]