Mandatory EU HTAR Implementation: Part 1

Pharmaceutical companies must prepare for the new European Health Technology Assessment Regulation (HTAR), which takes effect in January 2025. Designed to accelerate access to new drugs and reduce duplication of efforts, the HTAR will enable EU member states to jointly assess clinical effectiveness. This shift necessitates that companies establish new internal timelines and processes to effectively bring drugs and medical devices to market. It's essential for internal resources, skills, and roles to align with these upcoming changes.

Health Technology Assessment (HTA) is a multidisciplinary field that evaluates the health impact of new technologies, supporting policymakers in making informed decisions regarding reimbursement and health policy. The HTAR aims to create a unified framework for HTA across the EU, fostering innovation and collaboration among national bodies. Key elements include Joint Clinical Assessments (JCA) and Joint Scientific Consultations (JSC), which will help streamline the evaluation process and enhance market access for health technologies.

As the HTAR implementation begins, pharmaceutical companies need to plan for the mandatory submission of JCA dossiers, starting with oncology and advanced therapy medicinal products in 2025. ProPharma is positioned to assist organizations with this transition, offering expertise in regulatory affairs and HTA. To understand the HTAR requirements and prepare effectively, access the full article for detailed insights.