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HTA Regulation: JCA scope extends to orphan medicines

European CommissionLegislation milestone High impact in 425 days
Date
Thu 13 Jan 2028
Body
European Commission
Scope
EU
Subject
HTA & market access
Official source
eur-lex.europa.eu

Medicines designated as orphan medicinal products become subject to EU joint clinical assessment. Sponsors should plan JCA dossiers and PICO scoping alongside the MAA.

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