Conversations That Matter
No deviation’s Takeaways from 2025 ISPE Europe Annual Conference in London
Speaker: Dr. Evdokia Korakianiti – Head of the Quality and Safety Department at the European Medicines Agency (EMA)
At this year’s ISPE Europe Annual Meeting, Dr. Evdokia Korakianiti delivered a timely message: we are at a unique regulatory inflection point in Europe—one with the potential to reshape how we fight antimicrobial resistance (AMR), secure medicine access, and accelerate manufacturing innovation. Access, availability, and affordability remain critical issues, especially in the context of AMR. As global resistance grows and effective treatments dwindle, the regulatory system must become an enabler—not a barrier—to bringing novel, life-saving therapies to patients across Europe and beyond.
The New Pharmaceutical Legislation: A Catalyst for Change
The ongoing revision of the EU pharmaceutical legislation isn’t just about compliance—it’s about building a simpler, more connected framework that fuels innovation while ensuring high-quality, accessible medicines for patients.
Expected to be adopted by the end of 2025 and implemented by 2028–2029, the proposed updates include:
- A legal definition of personalized medicine, recognizing therapies tailored to individuals or specific patient groups.
- Regulatory sandboxes, offering safe spaces for developers to test innovations in real-world conditions.
- Provisions for decentralized manufacturing, crucial for short shelf-life or individualized products like advanced therapies.
- Platform technology registration, to allow faster, cross-referenced development of products using established platforms.
These changes aim to reduce barriers for smaller innovators and increase flexibility in how and where medicines are manufactured—both of which are essential in addressing AMR and broader healthcare challenges.
The Critical Medicines Act: Addressing Shortages Head-On
One of the most impactful developments is the Critical Medicines Act, designed to reduce medicine shortages by strengthening Europe’s manufacturing capacity. Within this framework, strategic projects will receive both scientific and operational support from regulatory agencies to:
- Modernize or expand capacity for critical medicines and APIs.
- Encourage adoption of advanced manufacturing technologies, such as continuous processing, robotics, and AI-based control systems.
These initiatives not only support security of supply but also help reduce manufacturing costs—making medicines more affordable and accessible.
EMA’s Support Systems: From Concept to Clinic
Behind the scenes, the European Medicines Agency (EMA) has built a robust network to support innovation throughout the product lifecycle. This includes:
- The Innovation Taskforce (ITF): for early informal advice to innovators.
- The PRIME scheme: to accelerate development of medicines for unmet medical needs.
- The Quality Innovation Group (QIG): a multidisciplinary team providing technical, regulatory, and scientific guidance—from site visits to 1:1 consultations.
So far, QIG has hosted five major “Listen and Learn” focus groups, covering topics like decentralized manufacturing, automation, and AI. It also contributes to new EU guidance, including updates to GMP Annex 11 and the recently drafted Annex 22 on AI use in manufacturing.
Digitalization and AI: Regulatory Readiness in the Age of Data
AI and digital tools are changing how we design, monitor, and scale pharmaceutical production. EMA is actively responding:
- The AI Reflection Paper outlines how AI/ML can be safely used across the lifecycle of a medicine.
- Annex 22 focuses on deterministic AI models used in GMP environments, with strong emphasis on human oversight.
- The QIG continues to provide preliminary guidance on process models, helping to build predictable paths for AI-enabled innovations.
These tools can help improve quality, reduce errors, and respond faster to public health needs, such as AMR outbreaks or pandemics.
Global Collaboration: Reducing Fragmentation, Boosting Trust
Innovation doesn’t stop at borders—and neither should regulation. EMA and its partners have piloted collaborative global assessments, achieving synchronized approvals within 120 days. This kind of regulatory convergence is essential to speeding up access to vital medicines worldwide, particularly in low- and middle-income countries.
In the context of AMR, global cooperation can dramatically reduce the time and cost of bringing new antibiotics to market and ensure their equitable distribution.
A Call to Industry: Let’s Build It Together
Innovation is a two-way street. Regulators can’t do it alone—they need industry, academia, and developers to show up, speak up, and collaborate early.
Dr. Korakianiti’s closing message was clear: “We have the tools. We have the mechanisms. Please come and talk to us.”
For those developing new antimicrobials, scaling digital platforms, or rethinking traditional supply models—now is the time to engage with Europe’s evolving regulatory ecosystem. Let’s build a future where every innovation, from AI-driven bioreactors to personalized bacteriophages, reaches the patient faster—and leaves no one behind.
As highlighted by Dr. Evdokia Korakianiti at ISPE2025:
“We are a partner in innovation. Our doors are open—please come talk to us.”
It was great to learn about how the European Medicines Agency (EMA) is building one of the most comprehensive innovation support ecosystems—from concept to clinic.
Three standout tools developers should know about:
- Innovation Taskforce (ITF) – the first stop for early, informal advice on breakthrough technologies and regulatory pathways.
- PRIME – accelerating the development of medicines that address unmet medical needs, with early and enhanced regulatory support.
- Quality Innovation Group (QIG) – a multidisciplinary team offering scientific advice, site visits, and 1:1 “safe harbor” discussions to support advanced manufacturing technologies.
If you’re innovating in life sciences—these are doors worth knocking on.
Want to go deeper?
Need help navigating QRM with the right balance of structure and sense? Get in touch with our expert team or explore our QRM services. Contact us at hello@nodeviation.com and let’s have a conversation that matters.
