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Global Life Sciences Update

HTA Regulation in the EU: A Blessing or a Burden for Market Access?

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Following the trialogue negotiations, on June 22, 2021, the Council of the European Union and the European Parliament reached a provisional agreement on the European Commission’s proposal for a European health technology assessment regulation (HTA Regulation), which aims to harmonize the clinical benefit assessment of health technologies across the EU. The scope of the proposal encompasses both medicinal products and medical devices, including in vitro diagnostics. The final agreed text is not available at the time of writing.

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