European Alliance for Personalised Medicine (EAPM) shared a post on LinkedIn:
“From Ambition to Execution: What EMA’s 2024 Results Mean for Europe.
Happy Friday.
Europe’s health-policy debate is finally shifting from aspiration to delivery and the EMA’s latest performance metrics show why this matters for patients, payers, and innovators.
EMA’s 2024 Annual Report records a step-change in regulatory output: 114 positive opinions for new human medicines, the highest total in 15 years with 46 medicines containing a new active substance.
Cancer remained the leading therapeutic area, with 28 oncology recommendations, alongside 28 biosimilars that can materially widen access and improve system sustainability.
On the veterinary side, EMA recommended 25 veterinary medicines (a record), including 14 vaccines.
Crucially, the report also demonstrates lifecycle regulation at scale.
EMA recommended 90 extensions of indication, often a faster route to real-world benefit than entirely new products.
Pharmacovigilance remained active and consequential: product information for 401 centrally authorised medicines was updated based on new safety data, reinforcing that authorisation is the start of oversight—not the end. And 92% of CHMP opinions (positive and negative) were reached by consensus, strengthening predictability and public trust.
On evidence generation, the direction is equally clear. DARWIN EU became fully operational, with access to health data covering 160 million patients across 16 European countries, enabling regulator-led real-world studies to complement clinical trials and fill evidence gaps.
Meanwhile, clinical-trials transparency has materially advanced: revised CTIS transparency rules mean more than 8,600 clinical trials with issued decisions are publicly searchable through CTIS.
These performance indicators land amid major EU policy shifts that will define the next decade of personalised medicine.
The AI Act entered into force on 1 August 2024, setting the world’s first horizontal framework for trustworthy AI—directly relevant to diagnostics, pharmacovigilance, and regulatory workflows.
The European Health Data Space (EHDS) Regulation entered into force on 26 March 2025, initiating a transition toward interoperable cross-border health data and secondary use for research, public health, and regulation.
The EU HTA framework began joint clinical assessments on 12 January 2025 for new cancer medicines and ATMPs, raising the stakes for evidence alignment between regulators and payers.
And all ongoing clinical trials had to transition to CTIS by 31 January 2025, embedding a new baseline for efficiency and transparency.
Finally, Europe is confronting the enabling ecosystem.
On 16 December 2025, the Commission published the European Biotech Act proposal and, in parallel, proposed a targeted simplification of MDR/IVDR to make procedures faster and more predictable-vital where diagnostics can be the rate-limiting step for patient access.”
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