How EMA and Its Partners Are Redefining the Rules: The EU Medicines Regulatory Strategy to 2028
In the pharmaceutical world, few regulatory updates truly warrant a second glance—especially for those who have witnessed multiple waves of reform. Yet the European Medicines Agencies Network Strategy (EMANS) for 2028 is different. This is a comprehensive redesign of the regulatory framework, shaped by new realities: supply chain instability, rising antimicrobial resistance, growing demands for faster access to innovative therapies, and the rapid evolution of data technologies.
EMA and national agencies are becoming active stakeholders throughout the lifecycle of a medicine, from early development to post-market surveillance. The question is no longer if this model will change, but how—and how fast.
The events of recent years have posed uncomfortable but necessary questions:
• Are we prepared for the next global health crisis?
• Are current measures against antimicrobial resistance sufficient?
• Can patients across the EU consistently access life-saving treatments without
⸻
Six Priorities of EMANS-2028
1. Ensuring Access and Supply Chain Resilience
The EU is reducing its dependency on third-country suppliers by diversifying production and enhancing its monitoring systems. New mechanisms are being implemented to proactively identify and mitigate shortages.
2. Digitalisation and Artificial Intelligence
EMA is moving beyond pilot programs and integrating AI into regulatory procedures, including dossier assessment and safety signal detection. Structured, high-quality data has become the key currency in this new reality.
3. Combating Antimicrobial Resistance (AMR)
A coordinated European strategy is being deployed—one that spans human and veterinary medicine. Efforts include incentivising new antibiotic development and enforcing responsible use of existing agents.
4. The One Health Approach
Regulatory frameworks now take into account the interconnected health of humans, animals, and the environment. Drug development and risk assessment processes will be shaped by this integrated view.
5. Crisis Preparedness
EMA and HMA are establishing fast-track authorisation pathways for emergencies, learning from the COVID-19 experience to ensure rapid access to critical therapies when needed.
6. Boosting the EU’s Global Competitiveness
Europe aims to be more than just a market for innovation; it is positioning itself as an attractive region for R&D and first-to-market launches. Early scientific advice and adaptive regulatory pathways are central to this strategy.
⸻
EMANS puts data quality and system integrity at the center of regulatory oversight. EMA now demands higher standards for data traceability and transparency across all submissions.
The Growing Role of Computer System Validation (CSV)
For any organisation engaged in clinical research, regulatory submissions, pharmacovigilance, or data management, validated IT systems are no longer optional—they are critical.
Computer System Validation (CSV) has become a central pillar in demonstrating compliance with EMA’s requirements and maintaining the integrity of submitted data.
Why it matters:
• EMA’s adoption of digital platforms and AI tools requires high levels of data transparency and system reliability.
• The ability to demonstrate validated systems can directly influence review timelines and eligibility for accelerated pathways.
• Readiness for EMA and other regulatory inspections now includes a clear, documented validation lifecycle for all critical computer systems.
⸻
Practical Steps for Companies
1. Audit and Validate Critical Systems
Align your IT infrastructure with GAMP 5 guidelines and ICH GCP E6(R3) standards. Validation is no longer an internal quality measure—it is a regulatory expectation.
2. Implement Robust Data Integrity Practices
Ensure end-to-end compliance with ALCOAC+ principles, from system architecture to daily operations. Data integrity is the new benchmark for regulatory success.
3. Invest in Competency Building
Technical infrastructure is only as strong as the teams managing it. Developing internal CSV expertise is essential for organisations aiming to remain competitive in the evolving EU regulatory environment.
⸻
Accelerate Readiness: The QARP CSV Training Program
For teams seeking a structured, practical approach to system validation, The QARP CSV Course offers a comprehensive solution.
This program is designed to meet the evolving demands of EMANS-2028 and provides hands-on guidance to:
• Ensure data integrity and compliance with ALCOAC+ principles
• Implement validation processes in line with GAMP 5 best practices
• Prepare for EMA, FDA, and other global regulatory inspections
• Manage system lifecycles in accordance with ICH GCP E6(R3)
The course is tailored for experienced professionals who want actionable insights and industry-proven tools to strengthen their regulatory frameworks.
Explore the course details here.
⸻
In Conclusion
Access to the market, speed of approval, and long-term success will depend not just on scientific merit, but on the maturity of an organisation’s data systems and validation practices.
Those who act now—by investing in robust data integrity and system validation—will not only meet the new regulatory standards, they will help shape the future of the European pharmaceutical landscape.
EMA and national agencies are becoming active stakeholders throughout the lifecycle of a medicine, from early development to post-market surveillance. The question is no longer if this model will change, but how—and how fast.
The events of recent years have posed uncomfortable but necessary questions:
• Are we prepared for the next global health crisis?
• Are current measures against antimicrobial resistance sufficient?
• Can patients across the EU consistently access life-saving treatments without
⸻
Six Priorities of EMANS-2028
1. Ensuring Access and Supply Chain Resilience
The EU is reducing its dependency on third-country suppliers by diversifying production and enhancing its monitoring systems. New mechanisms are being implemented to proactively identify and mitigate shortages.
2. Digitalisation and Artificial Intelligence
EMA is moving beyond pilot programs and integrating AI into regulatory procedures, including dossier assessment and safety signal detection. Structured, high-quality data has become the key currency in this new reality.
3. Combating Antimicrobial Resistance (AMR)
A coordinated European strategy is being deployed—one that spans human and veterinary medicine. Efforts include incentivising new antibiotic development and enforcing responsible use of existing agents.
4. The One Health Approach
Regulatory frameworks now take into account the interconnected health of humans, animals, and the environment. Drug development and risk assessment processes will be shaped by this integrated view.
5. Crisis Preparedness
EMA and HMA are establishing fast-track authorisation pathways for emergencies, learning from the COVID-19 experience to ensure rapid access to critical therapies when needed.
6. Boosting the EU’s Global Competitiveness
Europe aims to be more than just a market for innovation; it is positioning itself as an attractive region for R&D and first-to-market launches. Early scientific advice and adaptive regulatory pathways are central to this strategy.
⸻
EMANS puts data quality and system integrity at the center of regulatory oversight. EMA now demands higher standards for data traceability and transparency across all submissions.
The Growing Role of Computer System Validation (CSV)
For any organisation engaged in clinical research, regulatory submissions, pharmacovigilance, or data management, validated IT systems are no longer optional—they are critical.
Computer System Validation (CSV) has become a central pillar in demonstrating compliance with EMA’s requirements and maintaining the integrity of submitted data.
Why it matters:
• EMA’s adoption of digital platforms and AI tools requires high levels of data transparency and system reliability.
• The ability to demonstrate validated systems can directly influence review timelines and eligibility for accelerated pathways.
• Readiness for EMA and other regulatory inspections now includes a clear, documented validation lifecycle for all critical computer systems.
⸻
Practical Steps for Companies
1. Audit and Validate Critical Systems
Align your IT infrastructure with GAMP 5 guidelines and ICH GCP E6(R3) standards. Validation is no longer an internal quality measure—it is a regulatory expectation.
2. Implement Robust Data Integrity Practices
Ensure end-to-end compliance with ALCOAC+ principles, from system architecture to daily operations. Data integrity is the new benchmark for regulatory success.
3. Invest in Competency Building
Technical infrastructure is only as strong as the teams managing it. Developing internal CSV expertise is essential for organisations aiming to remain competitive in the evolving EU regulatory environment.
⸻
Accelerate Readiness: The QARP CSV Training Program
For teams seeking a structured, practical approach to system validation, The QARP CSV Course offers a comprehensive solution.
This program is designed to meet the evolving demands of EMANS-2028 and provides hands-on guidance to:
• Ensure data integrity and compliance with ALCOAC+ principles
• Implement validation processes in line with GAMP 5 best practices
• Prepare for EMA, FDA, and other global regulatory inspections
• Manage system lifecycles in accordance with ICH GCP E6(R3)
The course is tailored for experienced professionals who want actionable insights and industry-proven tools to strengthen their regulatory frameworks.
Explore the course details here.
⸻
In Conclusion
Access to the market, speed of approval, and long-term success will depend not just on scientific merit, but on the maturity of an organisation’s data systems and validation practices.
Those who act now—by investing in robust data integrity and system validation—will not only meet the new regulatory standards, they will help shape the future of the European pharmaceutical landscape.