The EMANS 2025 strategy period (2021–2025) has concluded, with EMA and HMA reporting significant progress across all six priority focus areas despite the challenges posed by COVID-19.
A successor strategy, EMANS 2028, was adopted in March 2026 under the theme "seizing opportunities in a changing medicines landscape."
Key Achievements by Strategic Focus Area
1. Availability & Accessibility of Medicines
- European Shortages Monitoring Platform (ESMP) launched January 2025 for shortage reporting
- Union list of critical medicines published (December 2023, updated 2024 and 2025)
- Shortage Prevention and Mitigation Plan (SPMP) templates published; pilot completed September 2025
- Joint HMA-EMA statement on biosimilar interchangeability issued
- Electronic product information (ePI) common standard developed and piloted
2. Data Analytics, Digital Tools & Digital Transformation
- DARWIN EU established: 40 data partners, 290+ million patient records across 18 countries, 110+ studies initiated
- Clinical study data pilot launched to analyze individual patient data during assessments
- AI initiatives: Guiding principles on large language models published; AI Observatory first annual report issued (July 2025); Scientific Explorer AI tool launched
- EU Data Quality Framework published (2023); RWD catalogues launched (February 2024)
- ICH M14 guideline on real-world data adopted (September 2025)
3. Innovation
- Clinical Trial Information System (CTIS) mandatory since January 2023
- ACT EU program delivering 11 priority actions including Pre-CTA and SAWP-CTCG pilots
- 3Rs Working Party established to minimize animal testing
- ICH M11 (clinical study protocol template) finalized December 2025
- EU Repurposing Project pilot completed (July 2025)
- Quality Innovation Group and Novel Therapies & Technologies Working Party progressing guidance on ATMPs and emerging technologies
4. Antimicrobial Resistance & Emerging Health Threats
- ESUAvet reports on antimicrobial sales/use in veterinary medicine published (2025)
- Emergency Task Force (ETF) made permanent under Regulation (EU) 2022/123
- Regulatory Agencies Global Network against AMR (RAGNA) initiated
- Commission Implementing Regulation on antimicrobials reserved for human use adopted
- COVID-19 Lessons Learned report published (December 2023)
5. Supply Chain Challenges
- EudraGMDP database integrated with Organisational Management System
- GMP Annex 1 (sterile manufacturing) entered into force August 2023
- Draft GMP Chapter 4, Annex 11, and Annex 22 (AI validation) published for consultation
- Joint Audit Programme extended to Good Distribution Practice
- Reliance pilot with PIC/s authorities successfully concluded
6. Sustainability & Operational Excellence
- New EMA fee regulation entered into force January 2025
- IncreaseNET initiative launched January 2024 for network capacity building
- EU Network Training Centre strategy updated; NCA remuneration scheme adopted
- IRIS platform fully implemented for all centralized post-authorization procedures (Q1 2025)
- Veterinary Union Product Database (UPD) operational since January 2022
- Vulnerability assessment methodology for critical medicines adopted November 2025
Key Implications for Industry
Shortages: Prepare for ESMP reporting obligations; develop SPMPs for critical products
ePI: Monitor go-live timelines; prepare systems for ePI submission
Data/AI: Align with EU Data Quality Framework; consider DARWIN EU collaboration for RWE generation
Clinical Trials: Use CTIS for all trials; consider Pre-CTA and SAWP-CTCG pilots
Manufacturing: Review compliance with new GMP Annex 1; prepare for Annex 22 AI requirements