The 2026–2028 Workplan of the European Medicines Agency’s Quality Innovation Group (QIG) outlines a strategic roadmap that is set to shape the future of pharmaceutical manufacturing, quality control, and regulatory science across Europe. The plan confirms the growing importance of innovation-driven approaches in the production and oversight of medicines: particularly, as the sector accelerates its adoption of artificial intelligence, digital technologies, and next-generation manufacturing models.
In the short term, the QIG will focus on how best to support innovation in the manufacture and control of medicinal products. Key areas under consideration include pharmaceutical process models, the application of artificial intelligence in quality and production environments, and the broader digitalisation of manufacturing and regulatory workflows. Emerging technologies such as 3D printing, platform-based production systems, personalised medicines, continuous manufacturing, and decentralised manufacturing are also expected to play a central role in the group’s activities.
The importance of collaboration
A major objective of the Workplan is the continued strengthening of the EU regulatory network. In this context, the QIG will provide support across all quality and Good Manufacturing Practice (GMP) aspects related to advanced manufacturing technologies. Ensuring that innovative production methods can be implemented safely, consistently, and in compliance with EU standards remains a critical priority, particularly as automation and digital transformation reshape pharmaceutical supply chains.
The Workplan also highlights the importance of stakeholder engagement and international collaboration. This reflects the increasingly global nature of pharmaceutical innovation, where regulatory convergence and shared best practices are essential for enabling the responsible deployment of new manufacturing approaches across regions. Looking further ahead, the long-term strategic goals of the Quality Innovation Group prioritise transformative technologies such as 3D bioprinting, artificial intelligence, automation and robotics, as well as novel regulatory concepts aligned with evolving pharmaceutical legislation. Topics such as decentralised manufacturing models, platform technologies, bioinformatics, next-generation sequencing, and enhanced traceability systems for personalised medicines are expected to become increasingly relevant in the coming years.
From regulation to innovation
From a regulatory science perspective, planned actions will focus on strengthening research and quality innovation within the EU network, while improving the scientific and regulatory capacity, resilience, and overall capability of European authorities. The QIG will also support the implementation of the new pharmaceutical legislation, working in close collaboration with other EMA Committees and Working Parties. Overall, the EMA Quality Innovation Group Workplan for 2026–2028 positions innovation, digitalisation, and AI-driven manufacturing as central pillars of the European pharmaceutical landscape. Its priorities will have direct implications not only for pharmaceutical companies, but also for IT professionals, automation experts, and stakeholders involved in the digital transformation of life sciences manufacturing.