In 2021, the adoption of the legislation for joint European Health Technology Assessment (EU HTA) initiated a new era for HTA. The HTA Regulation (HTAR) aims to enable development of a joint perspective on clinical aspects of drugs, in vitro diagnostics (IVDs) and high-risk medical devices.
While all stakeholders agree that the pan-EU collaboration on HTA and harmonization of processes and requirements is valuable, the shift to a mandatory process is not without any pitfalls. In this paper, we outline some of the implications of pan-EU HTA of drugs and how industry should prepare by describing:
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