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
EMA, AI and digitalization

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

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

Bern and Brussels seal new research partnership

As part of a broader package of bilateral agreements negotiated between the EU and the Swiss Confederation in 2024, Switzerland will join several R&I Union programmes, including Horizon Europe, Digital Europe, and EU4Health

Newsstand

  • Supplement to n.5 - October 2025 NCF International n.2 - 2025
  • NCF International n.1 - 2025
  • Supplemento to n.9 - October 2024 NCF International n.3 - 2024