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Regulatory Affairs Insights
Guiding Principles of Good AI Practice in Drug Development: What Every Regulatory Professional Needs to Know
In January 2026, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) jointly published one of the most significant regulatory science documents in recent memory: Guiding Principles of Good AI Practice in Drug Development. For the first time, the world's two most influential regulatory authorities have aligned on a shared framework governing how artificial intelligence must be developed, validated, documented, and managed across the entire pharm
Jul 912 min read
Revising EU GMP Annex 15: What the Concept Paper Means for the Industry
In January 2026, the EMA GMP/GDP Inspectors Working Group and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) jointly published a concept paper proposing the most significant revision to EU GMP Annex 15 in over a decade. The public consultation that followed — open from 9 February to 9 April 2026 — has generated substantial industry debate, and for good reason. What is being proposed is not a cosmetic update to existing guidance. It is a structural overhaul that w
Jul 912 min read
Joint Scientific Consultations (JSCs): What They Are and Who They Can Help
If you have spent any time navigating the EU Health Technology Assessment (HTA) landscape in 2025 or 2026, you will have encountered a question that stops many development teams in their tracks: how do we design a clinical trial that satisfies both the EMA for marketing authorisation and EU HTA bodies for the Joint Clinical Assessment — when their evidence requirements do not always align? The answer, in regulatory terms, is the Joint Scientific Consultation (JSC) — one of
Jul 816 min read
New PRIME Tools to Accelerate Development of Medicines in the EU: What It Means for Industry and Regulatory Careers
In March 2026, the European Medicines Agency (EMA) made a landmark announcement. After completing a two-year pilot programme, the agency formally launched three major new features under its PRIME (PRIority MEdicines) scheme — powerful tools designed to improve how innovative medicines reach patients across the European Union. For pharmaceutical developers, biotech companies, and the regulatory professionals who support them, this is not a routine administrative update. It rep
Jul 213 min read
Type IA Variations: Why "Simple" Variations Are Never as Simple as They Look
Ask any experienced regulatory affairs professional about Type IA variations and most will tell you the same thing: they look easy, they are not. Known in the industry as "do and tell" procedures, Type IA variations represent the process by which pharmaceutical companies make minor changes to their marketing authorisation (MA) dossiers — implementing the change first, then notifying the relevant regulatory authority. No prior approval needed. In theory, this is the most strai
Jun 2314 min read