EMA 2025 Annual Report Annexes: Committees, Opinions, and Governance

Key Takeaways

• The document comprises 24 annexes documenting EMA committee memberships, 2025 scientific opinions, and regulatory decisions across human and veterinary medicines, orphan products, herbal monographs, and paediatric investigations.
• Governance annexes (1–9) list members of the Management Board, Committee for Medicinal Products for Human Use (CHMP), Pharmacovigilance Risk Assessment Committee (PRAC), Committee for Veterinary Medicinal Products (CVMP), and five additional scientific committees.
• Regulatory output annexes (10–18) record CHMP opinions on initial evaluations and therapeutic indication extensions, CVMP opinions on veterinary medicines, orphan designations, herbal monographs, paediatric investigation plans, and referral procedure overviews.
• Administrative annexes (19–24) cover budget summaries, establishment plan details, litigation activities, access-to-documents requests, clinical data publication, and staff publications.
• Rui Santos Ivo served as Management Board Chair in 2025, with Bruno Sepodes chairing the CHMP and Ulla Wandel Liminga chairing the PRAC.

What This Document Covers

This annex volume serves as the supporting reference material for the EMA's 2025 annual report. It compiles detailed membership rosters for all major governance and scientific committees, records the full output of regulatory decisions and scientific opinions issued in 2025, and captures administrative transparency data including budget, litigation, document access requests, and publication activity by Agency staff and experts.

Why It Matters for Pharma Teams

For regulatory and policy teams, the annexes enable identification of committee structures, confirmation of 2025 decision pathways, and location of the EMA bodies responsible for specific opinions or referrals. The document is particularly valuable for governance mapping and stakeholder tracking, allowing cross-functional teams to monitor the Agency's published outputs and EMA committee membership changes without relying on secondary sources or real-time database queries.

Frequently Asked Questions

Who chaired the EMA's major committees in 2025?

Rui Santos Ivo chaired the Management Board; Bruno Sepodes chaired the Committee for Medicinal Products for Human Use (CHMP); Ulla Wandel Liminga chaired the Pharmacovigilance Risk Assessment Committee (PRAC). Additional committee chairs are listed in Annexes 4–8 for veterinary, orphan, herbal, and paediatric functions.

How are the annexes organized?

Annexes 1–9 cover governance and committee memberships. Annexes 10–18 document 2025 regulatory opinions and decisions, including CHMP opinions on initial evaluations and therapeutic indications, CVMP opinions on veterinary medicines, orphan designations, herbal monographs, paediatric investigation plans, and referral procedures. Annexes 19–24 address budget, establishment plan, litigation, access to documents, clinical data publication, and staff publications.

What is the source and scope of this document?

This is an official annex package issued by the European Medicines Agency in 2026 (reference EMA/73144/2026) as supporting material to the Agency's 2025 annual report. It is a reference and transparency document designed to provide stakeholders with detailed records of EMA governance, committee composition, and regulatory activity rather than a narrative policy analysis.

Where can I find information about EMA committee membership changes in 2025?

Committee membership rosters and changes are documented in Annexes 1–8. Footnotes within each annex indicate member replacements, role swaps between members and alternates, and the effective dates of those changes throughout 2025.

What regulatory decisions are included in the 2025 annexes?

Annexes 10–18 compile CHMP opinions on initial evaluations and therapeutic indication extensions, guidelines and concept papers adopted by the CHMP, CVMP opinions on veterinary medicinal products, orphan product designations, European Union herbal monographs, paediatric investigation plans and waivers, and referral procedure overviews for both human and veterinary medicines.

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