The EU HTA regulation: a new frontier for access to innovative technologies

European Pharmaceutical Review

23 August 2022 - A new health technology regulation is due to be applied to help EU countries determine the effectiveness of novel technologies and decide on pricing and reimbursement by health insurers or health systems.

The regulation will be applied by 12 January 2025 and will therefore take three years to become effective in Member States (and thus to fully appreciate its impact). 

It introduces an evidence based process (health technology assessment) that will allow the competent EU and national authorities to determine the effectiveness of new or existing health technologies (eg, medicinal products, medical devices, in vitro diagnostic medical devices, medical procedures and measures to prevent, diagnose or treat diseases).

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Michael Wonder

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Michael Wonder