BOE Importance: 6/10

New regulation of health technology assessment to decide what the NHS finances

29 May 2026 Effective: 29 May 2026 43 views
Who is affected:
Pharmaceutical industry, medical device manufacturers, regional health authorities, patients and NHS

Summary

The Government regulates how medicines, medical devices and other technologies are evaluated before the NHS decides to finance them. A system is created with two specialized offices to ensure independent and transparent evaluations.

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This Royal Decree establishes the legal framework for health technology assessment (HTA) in Spain, aligning it with European Regulation 2021/2282. It creates the 'System for the evaluation of health technologies' with two Offices: AEMPS for medicines and RedETS for non-pharmacological technologies. The evaluation cover…

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Full official title

Real Decreto 415/2026, de 27 de mayo, por el que se regula la evaluación de tecnologías sanitarias.

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Affected sectors

SMEs Technology Healthcare

Categories

Tax & Revenue Labour & Employment Corporate & Business Data Protection Social Security European Regulations Grants & Subsidies Other Regulations Public Sector Education Energy Agriculture & Fisheries Real Estate

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