Pharma · EU
EU HTA Assessments
EU joint clinical assessments of new medicines widen to orphan medicines in 2028 and all in 2030.
ForHeads of market access and health technology assessment at pharmaceutical companies.
What’s changing, and when
The Health Technology Assessment Regulation has applied since 12 January 2025, starting with new cancer medicines and advanced therapies. Orphan medicines join from 13 January 2028, and all other medicines in scope from 13 January 2030. Each assessment is carried out once at EU level from a single dossier, while pricing and reimbursement stay national.
- Jan 2025 Cancer medicines and advanced therapies
- Jan 2028 Orphan medicines join
- Jan 2030 All other medicines in scope join
Why it can’t happen in one step
Each dossier draws on trial evidence held by sponsors, partners and investigators, and it has to be shared with assessors in every Member State on a fixed timetable.
How Polymonial carries you across
- Share dossiers with assessors, secure for them alone.
- Evidence records that cannot be quietly changed.
Trust that travels.
Secure, trusted and under your control.