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

EMA's 2025 Annual Report Annexes compile committee memberships and scientific opinions across human and veterinary medicines. Used with EMA's news tally of 104 human-medicine recommendations, they form a practical regulatory reference set.

Key Takeaways

• EMA published Annexes to the 2025 Annual Report covering committee memberships and scientific outputs across 24 annexes.
• EMA's accompanying news release states the agency recommended 104 human medicines for marketing authorisation in 2025, including 38 with a new active substance.
• Veterinary recommendations included 13 products with a new active substance, with vaccines a large share of the veterinary set.
• Annex 10 records CHMP opinions on initial evaluations and extensions of indication; Annex 14 covers COMP orphan designation opinions.

What are the EMA 2025 annexes for?

The Annexes PDF is the tabular companion to EMA's narrative annual report. It lists Management Board and scientific committee memberships, then catalogs 2025 opinions and administrative outputs.

Governance annexes (1–9) cover bodies such as CHMP, PRAC, CVMP, COMP, HMPC, CAT, and related working groups. Output annexes (10–18+) record opinions, guidelines, orphan designations, herbal monographs, PIPs, and referrals.

Which headline totals should readers pair with the annex tables?

EMA's news release on the 2025 annual report states the agency recommended 104 human medicines for marketing authorisation, of which 38 had a new active substance. The same release notes three positive opinions for medicines intended for use outside the EU and strong veterinary recommendation volume, including 13 veterinary products with a new active substance.

Those headline counts help interpret Annex 10 and related opinion lists without inventing row-level tallies from memory.

Which annexes matter most for BD and regulatory intelligence?

For human medicines diligence, start with:

• Annex 10 — CHMP opinions on initial evaluations and extensions of therapeutic indication
• Annex 11 — CHMP guidelines and concept papers
• Annex 14 — COMP orphan designation opinions
• Annex 16 — PDCO opinions and PIP/waiver decisions

Veterinary teams should prioritize Annex 12 (CVMP opinions) and Annex 13 (CVMP guidelines).

Where does EMA publish the parent report and annex downloads?

EMA's annual reports and work programmes page links the digital 2025 report, the annexes PDF, and selected annex extracts such as Annex 10. The agency also published a news summary highlighting approval-volume themes for 2025.

What the annexes do not replace

Annex tables are not a substitute for the full EPAR, SmPC, or CHMP assessment report for a specific product. They also do not by themselves disclose confidential dossier data used inside the assessment. Use annexes for portfolio scanning, then open the product-level EMA documents before making a regulatory or BD call.

How should teams operationalize the 2025 package?

Build a watchlist from Annex 10 new actives and extensions, cross-check orphan status via Annex 14, and map paediatric obligations via Annex 16. Revisit the human-medicines highlights PDF when you need narrative context around PRIME, conditional approvals, or ATMPs.

How to read Annex 10 alongside the 104-medicine headline

Annex 10 is the operational list BD teams export when they want product-level CHMP outcomes for 2025. Pair each row with EMA's headline that 104 human medicines received a marketing-authorisation recommendation and that 38 of those carried a new active substance. That pairing prevents over-reading a single annex line as a completed Commission decision.

The human-medicines highlights PDF further breaks out tools such as PRIME, conditional marketing authorisations, and ATMPs. Use those categories when you need a 2025 cohort slice rather than inventing share-of-pipeline percentages.

Veterinary readers should apply the same discipline to Annex 12: EMA reported another strong year of veterinary recommendations, including 13 products with a new active substance and a large vaccine share, but the annex tables remain the place to verify individual CVMP opinions.

Finally, keep Annex 14 (orphan designations) and Annex 16 (PIP and waiver decisions) in the same diligence pack. Orphan and paediatric obligations often decide whether a 2025 CHMP opinion is commercially actionable in the EU5 versus smaller markets.

Related NovaPharma coverage

• EMA recommended 104 human medicines in 2025
• FDA guidance on sharing potential NDA patent information
• FDA MRD guidance in multiple myeloma

Frequently Asked Questions

How many human medicines did EMA recommend in 2025?

EMA's annual-report news release states the agency recommended 104 human medicines for marketing authorisation in 2025, including 38 with a new active substance.

What do the 2025 annexes contain?

The annexes compile committee memberships plus catalogs of scientific opinions and related outputs, including CHMP, CVMP, COMP, HMPC, and PDCO materials across roughly two dozen annexes.

Which annex lists CHMP opinions on new evaluations?

Annex 10 records CHMP opinions on initial evaluations and extensions of therapeutic indication in 2025.

Primary Sources

1. EMA: Annexes – 2025 annual report (PDF)
2. EMA news: 2025 annual report approval numbers
3. EMA: Annual reports and work programmes hub
4. EMA: Human medicines in 2025 highlights (PDF)