August 9, 2026

Newsletter

The European Post

Policy • Diplomacy • Strategic Insight

LATEST
Medicine Shortages Move to the Heart of Europe’s Pharma ResetJapan Becomes Europe’s Closest Security Partner in AsiaCan Europe’s New Zealand Deal Anchor It in the Pacific?Chip Research Binds Europe and South Korea CloserMinimum Prices Replace Tariffs in Europe’s China Car DealBrussels and Beijing Keep Talking While the Trade Gap WidensKorean Weapons and EU Loans Now Bankroll Europe’s RearmamentNew EU Gas Market Rules Take Effect With Consumer SafeguardsDeforestation Regulation Holds Its December Deadline Despite CutsDigital Omnibus Delays Europe’s High-Risk AI Deadline to 2027Europe’s Schools Confront a Widening Basic Skills GapRule of Law Report Finds Progress but Trust Still LagsIRIS2 Gains 66 Satellites as Brussels Signs the Rollout DealNature Restoration Plans Come Due as Member States Race a DeadlineECB Rates Hold at 2.25 Percent as Frankfurt Waits on the DataEU Budget Talks Turn to Cohesion as Ireland Takes OverWildfire Response Stretches Europe’s Emergency Fleet ThinCan Europe’s Quantum Plan Match Its Big Ambitions?Armenia Edges West as Moscow’s Grip Slips AwayEurope Inherits the World’s Aid Bill It Cannot Fully PayMedicine Shortages Move to the Heart of Europe’s Pharma ResetJapan Becomes Europe’s Closest Security Partner in AsiaCan Europe’s New Zealand Deal Anchor It in the Pacific?Chip Research Binds Europe and South Korea CloserMinimum Prices Replace Tariffs in Europe’s China Car DealBrussels and Beijing Keep Talking While the Trade Gap WidensKorean Weapons and EU Loans Now Bankroll Europe’s RearmamentNew EU Gas Market Rules Take Effect With Consumer SafeguardsDeforestation Regulation Holds Its December Deadline Despite CutsDigital Omnibus Delays Europe’s High-Risk AI Deadline to 2027Europe’s Schools Confront a Widening Basic Skills GapRule of Law Report Finds Progress but Trust Still LagsIRIS2 Gains 66 Satellites as Brussels Signs the Rollout DealNature Restoration Plans Come Due as Member States Race a DeadlineECB Rates Hold at 2.25 Percent as Frankfurt Waits on the DataEU Budget Talks Turn to Cohesion as Ireland Takes OverWildfire Response Stretches Europe’s Emergency Fleet ThinCan Europe’s Quantum Plan Match Its Big Ambitions?Armenia Edges West as Moscow’s Grip Slips AwayEurope Inherits the World’s Aid Bill It Cannot Fully Pay
August 9, 2026

Newsletter

The European Post

Policy • Diplomacy • Strategic Insight

LATEST
Medicine Shortages Move to the Heart of Europe’s Pharma ResetJapan Becomes Europe’s Closest Security Partner in AsiaCan Europe’s New Zealand Deal Anchor It in the Pacific?Chip Research Binds Europe and South Korea CloserMinimum Prices Replace Tariffs in Europe’s China Car DealBrussels and Beijing Keep Talking While the Trade Gap WidensKorean Weapons and EU Loans Now Bankroll Europe’s RearmamentNew EU Gas Market Rules Take Effect With Consumer SafeguardsDeforestation Regulation Holds Its December Deadline Despite CutsDigital Omnibus Delays Europe’s High-Risk AI Deadline to 2027Europe’s Schools Confront a Widening Basic Skills GapRule of Law Report Finds Progress but Trust Still LagsIRIS2 Gains 66 Satellites as Brussels Signs the Rollout DealNature Restoration Plans Come Due as Member States Race a DeadlineECB Rates Hold at 2.25 Percent as Frankfurt Waits on the DataEU Budget Talks Turn to Cohesion as Ireland Takes OverWildfire Response Stretches Europe’s Emergency Fleet ThinCan Europe’s Quantum Plan Match Its Big Ambitions?Armenia Edges West as Moscow’s Grip Slips AwayEurope Inherits the World’s Aid Bill It Cannot Fully PayMedicine Shortages Move to the Heart of Europe’s Pharma ResetJapan Becomes Europe’s Closest Security Partner in AsiaCan Europe’s New Zealand Deal Anchor It in the Pacific?Chip Research Binds Europe and South Korea CloserMinimum Prices Replace Tariffs in Europe’s China Car DealBrussels and Beijing Keep Talking While the Trade Gap WidensKorean Weapons and EU Loans Now Bankroll Europe’s RearmamentNew EU Gas Market Rules Take Effect With Consumer SafeguardsDeforestation Regulation Holds Its December Deadline Despite CutsDigital Omnibus Delays Europe’s High-Risk AI Deadline to 2027Europe’s Schools Confront a Widening Basic Skills GapRule of Law Report Finds Progress but Trust Still LagsIRIS2 Gains 66 Satellites as Brussels Signs the Rollout DealNature Restoration Plans Come Due as Member States Race a DeadlineECB Rates Hold at 2.25 Percent as Frankfurt Waits on the DataEU Budget Talks Turn to Cohesion as Ireland Takes OverWildfire Response Stretches Europe’s Emergency Fleet ThinCan Europe’s Quantum Plan Match Its Big Ambitions?Armenia Edges West as Moscow’s Grip Slips AwayEurope Inherits the World’s Aid Bill It Cannot Fully Pay

Drug Approvals Held Near a Record as Brussels Sped Reviews

Hera Briem
Regulatory Monitor, Democratic Governance and Rule of Law

Patients across the bloc had an unusually strong year for new treatments, according to figures the European Medicines Agency’s management board signed off this month. The agency recommended 104 human medicines for marketing authorisation in 2025, of which 38 contained a new active substance never before cleared in the Union. It was the second-highest annual tally in fifteen years, and a reminder that for all the friction in EU health policy, the bloc’s central approval pipeline is running close to full capacity.

The headline number rewards a closer look. Among the positive opinions were 16 orphan medicines aimed at rare diseases, 4 advanced therapy products that use genes or cells rather than conventional chemistry, and 6 medicines carried through the agency’s PRIME scheme for priority treatments addressing unmet need. Forty-one were biosimilars, the cheaper follow-on versions of biological drugs whose patents have lapsed, and ten were generics. That mix matters because it shapes what reaches pharmacy shelves and at what price. A wave of biosimilars tends to drag down the cost of expensive biologic therapies, freeing health-system budgets for newer products.

Oncology again led the field for genuine novelty, with 14 of the new active substances targeting cancer. Endocrinology produced the largest raw count of recommendations at 29, though most of those were biosimilars rather than first-in-class compounds. The pattern tracks where pharmaceutical investment has concentrated for a decade: cancer and metabolic disease, including the diabetes and obesity treatments that have reshaped the sector’s economics. Veterinary medicine had a strong year too, with 30 recommendations, the highest for a second year running and a quiet sign of how much animal-health and food-safety work flows through the same regulator.

The board adopted the annual report alongside preparations for the new EU pharmaceutical legislation, the biggest overhaul of the bloc’s medicines rules in two decades. That reform aims to shorten approval times, tighten obligations on companies to supply all member states rather than only the most profitable markets, and rework the incentives that govern how long a new drug enjoys protection from competition. The strong 2025 figures will feed both sides of that debate. Industry will point to the output as proof the system works and should not be destabilised. Reform advocates will counter that volume says little about access, since a medicine approved in Brussels can still take years to reach patients in smaller or poorer member states.

That access gap is the real story behind the numbers. A central recommendation from the agency only opens the door; pricing and reimbursement decisions stay national, and they move at very different speeds. Patients in wealthier western states routinely get new therapies long before those in parts of central and eastern Europe, a disparity the pharmaceutical reform is meant to narrow but which no approval statistic can fix on its own.

Three accelerated assessments and eight conditional approvals in the 2025 count show the agency leaning into faster routes for the most urgent cases, a flexibility built up during the pandemic and now part of the standard toolkit. The challenge is doing that without lowering the evidence bar, since conditional clearances rely on companies delivering confirmatory data later. For now the figures suggest a regulator managing a heavy and increasingly complex workload well. Whether that translates into faster, fairer access across all twenty-seven members is the question the coming legislation, not the annual report, will have to answer.

Comments