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November 6, 2026

Newsletter

The European Post

Policy • Diplomacy • strategic insight

LATEST
Deposit Insurance Scheme Withdrawn After A Decade Of TalksUnanimity Rule Ends Energy Taxation Directive After 5 YearsNon-Household Electricity Prices Fall 5.4% In First Half Of 2026EU Maritime Security Strategy Report Shows Progress On All Six GoalsNew EU Customs Handling Fee Lands On Every Distance Sale OnlineWest and Central Africa Aid Reaches €235 Million As Crises ConvergeEU-Armenia Summit Delivers Transport Links But No Membership PathCohesion Policy Fight Pits Regions Against National PlansMilitary Mobility Funding Call Closed, Results Due 2027Pay Transparency Directive Deadline Missed By Most StatesDigital Omnibus on AI Delays High-Risk Rules To December 2027Ukraine Accession Roadmap Offers Steps To Membership Without A DateConciliation Looms As EU Budget 2027 Faces 16 November DeadlineImporters Count Down To EU Deforestation Regulation DateFactories Slow As Euro Area Industrial Production DropsCircular Economy Act Slips A Week As Textile Makers PushDAC Recast Would Fold Nine Tax Cooperation Directives Into OneThird-Country Satellites Face EU Space Act Certification HurdleMexico Signature Gives EU-Mexico Agreement Its First Real TestGulf Partnership Stalls as the EU-GCC Summit Loses Its New DateDeposit Insurance Scheme Withdrawn After A Decade Of TalksUnanimity Rule Ends Energy Taxation Directive After 5 YearsNon-Household Electricity Prices Fall 5.4% In First Half Of 2026EU Maritime Security Strategy Report Shows Progress On All Six GoalsNew EU Customs Handling Fee Lands On Every Distance Sale OnlineWest and Central Africa Aid Reaches €235 Million As Crises ConvergeEU-Armenia Summit Delivers Transport Links But No Membership PathCohesion Policy Fight Pits Regions Against National PlansMilitary Mobility Funding Call Closed, Results Due 2027Pay Transparency Directive Deadline Missed By Most StatesDigital Omnibus on AI Delays High-Risk Rules To December 2027Ukraine Accession Roadmap Offers Steps To Membership Without A DateConciliation Looms As EU Budget 2027 Faces 16 November DeadlineImporters Count Down To EU Deforestation Regulation DateFactories Slow As Euro Area Industrial Production DropsCircular Economy Act Slips A Week As Textile Makers PushDAC Recast Would Fold Nine Tax Cooperation Directives Into OneThird-Country Satellites Face EU Space Act Certification HurdleMexico Signature Gives EU-Mexico Agreement Its First Real TestGulf Partnership Stalls as the EU-GCC Summit Loses Its New Date

Scientific Advice Demand Jumps 26 Percent In EMA Mid-Year Report

Jóhannes Guðnason
Legislative Affairs Editor, Health and Wellbeing

Leiden: Requests for scientific advice and protocol assistance rose to 485 in the first half of 2026, up from 384 in the same period of 2025, according to the EMA mid-year report dated 29 October 2026. That is a gain of about 26 percent in twelve months. The European Medicines Agency now forecasts 885 requests for the full year, an increase of 13 percent.

The EMA mid-year report gives a detailed picture of a regulator under rising pressure. Scientific advice is the service through which developers ask the agency how to design trials before they file for approval, so growing demand points to a busy pipeline of new products. The agency also peer reviewed 850 safety signals in the half-year, compared with 716 a year earlier.

The application figures tell a more cautious story. The agency received 29 initial marketing authorisation applications for human medicines in the first six months of 2026, and it cut its full-year forecast from 78 to 74. Veterinary medicines moved the other way, with seven initial applications received and the annual forecast raised from 23 to 26. Variations to existing authorisations reached 4,194, with a full-year forecast of 8,949.

The report also records milestones in the wider European medicines framework. The first joint clinical assessment under the Health Technology Assessment Regulation was published on 9 June 2026, a step that supports faster and more uniform decisions on whether new treatments deliver added benefit. Council and Parliament reached a provisional agreement on the Critical Medicines Act on 12 May 2026, and the agency is expanding the European Shortages Monitoring Platform to help track supply risks.

Capacity matters because demand is rising while the agency’s workforce was 991 at the end of the second quarter. A regulator that must handle more advice requests, thousands of variations and a growing signal workload needs predictable resources. The EMA mid-year report does not say that the agency is struggling, but its forecasts show where the strain is likely to appear.

The workload figures also show why the agency keeps asking for stable funding. Each scientific advice request needs expert time from committees and national authorities, and the 26 percent rise in 485 requests lands on the same staff who review applications and variations. The EMA mid-year report therefore reads as both a progress update and a warning about capacity.

For patients and companies, the practical lesson from the EMA mid-year report is that European medicines regulation is getting busier before the new pharmaceutical rules and the Critical Medicines Act take full effect. Developers should expect strong competition for advice slots, while policymakers should watch whether the agency’s budget keeps pace with its workload.

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