terça-feira, 26 de março de 2024

Europe’s new Health Technology Assessment Regulation (HTAR) on the horizon

 In early 2025, Europe will implement a uniform, pan-EU framework under the new Health Technology Assessment Regulation (HTAR), addressing disparities in evaluating the clinical value of pharmaceuticals and medical devices.

The HTAR introduces a Joint Clinical Assessment (JCA) across the continent, a framework mandating that all 27 Member States adopt standardised procedures for evaluating the clinical evidence of newly submitted products or devices.

This special report looks at the opportunities, concerns, stakeholders’ readiness and ongoing administrative complexities. (...)

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