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Regulatory Affairs · Regulation · 3 November 2026
The Regulation on health technology assessment, Regulation (EU) 2021/2282, has applied since 12 January 2025. It introduces joint clinical assessments: one scientific assessment of the relative clinical effectiveness of a medicine, carried out at EU level for all member states.
The scope grows in steps. Since January 2025 it covers medicines with new active substances for the treatment of cancer and advanced therapy medicinal products (ATMPs). Orphan medicinal products follow from 13 January 2028, and the full scope of the Regulation applies from 13 January 2030.
A joint clinical assessment looks at the clinical evidence only. It does not judge the value of a medicine or recommend a price: decisions on pricing and reimbursement stay with each member state, which gives due consideration to the joint report in its national assessment.
The procedural rules for medicines are set out in Implementing Regulation (EU) 2024/1381. The assessment runs in parallel with the marketing authorisation procedure at the European Medicines Agency, so the evidence dossier has to be prepared on a tight timeline.
For companies planning launches in the EU, the evidence strategy for a joint clinical assessment now belongs to the early planning of a product, alongside the regulatory strategy.
Sources: EUR-Lex — Regulation (EU) 2021/2282 on health technology assessment · European Commission — Joint clinical assessment for medicinal products (factsheet)
