Manufacturing
Concept paper on the revision of Annex 15
As agreed during the 115th meeting of EMA’s GMP/GDP Inspectors Working Group (GMDP IWG), EMA has launched a targeted revision of Annex 15 of the GMPs. The consultation period on the Concept Paper will remain open until 9 April 2026
QIG workplan 2026-2028: AI, digitalisation and advanced manufacturing
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
R&D
The role of quantum mechanics in drug discovery
Quantum mechanics allows us to obtain very accurate results in the study of molecules. Over the years, numerous computational methods have been developed that are capable of studying the system under examination with different approaches, always rigorously based on quantum theories
EFPIA’s report on AI across the medicines lifecycle
AI is increasingly reshaping the pharmaceutical industry, moving beyond experimental use cases to become a concrete component of regulatory decision-making and patient-facing processes. Its growing adoption is redefining how medicinal products are researched, developed, approved and monitored throughout their lifecycle















