Mandatory HTAR Implementation In The EU: Part 2

As the Health Technology Assessment Regulation (HTAR) approaches its implementation in January 2025, pharmaceutical companies must prepare for new compliance requirements that will significantly impact their market access strategies. This includes the mandatory submission of a Joint Clinical Assessment (JCA) report to the European Commission for products targeting oncology and advanced therapies. Companies are also encouraged to engage in Joint Scientific Consultations (JSC) with regulatory experts to refine their development plans and ensure alignment with health technology assessment bodies. The HTAR aims to streamline assessments across the EU, promoting quicker patient access to innovative treatments while fostering collaboration among national HTA bodies.

Key steps in the preparation process involve developing assessment scopes, conducting systematic literature reviews, and creating comprehensive JCA dossiers within strict timelines. ProPharma offers specialized support to help companies navigate the complexities of the JCA and JSC processes, ensuring they remain compliant with the new requirements. To learn more about how to effectively manage these upcoming changes, access the full article.