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How Pharmacists Can Move Into the Pharmaceutical Industry Through Regulatory Affairs
Community and hospital pharmacy is one of the most intellectually demanding qualifications in healthcare. Pharmacists spend four to five years studying pharmacokinetics, drug interactions, pharmaceutical sciences, clinical practice and patient counselling. They emerge with a depth of pharmaceutical knowledge that most people in the healthcare system simply don’t have. And then, for a significant proportion, they spend their careers in environments that use only a fraction of
Jul 284 min read
The EU HTA Regulation Is Reshaping How Clinical Evidence Supports Market Access Across Europe
On 30 April 2026, a milestone quietly passed that will redefine how innovative medicines reach patients across the European Union. The HTA Coordination Group (HTACG) approved the very first Joint Clinical Assessment (JCA) report in history — covering tovorafenib (Ojemda®), Ipsen's treatment for paediatric low-grade malignant glioma. Completed well within the 30-day timeline from marketing authorisation, it marked the first real-world product of a regulatory and market access
Jul 2814 min read
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
How to Get Into Regulatory Affairs With Pharmaceutical Industry Experience (But No RA Background)
You work in pharma. You want to move into regulatory affairs. You’re applying and not getting through. Here’s exactly why — and exactly what to do about it. You Already Work in the Industry. Why Is RA Still Out of Reach? It seems like it should be straightforward. You work in the pharmaceutical industry — in quality, in manufacturing, in analytical development, in clinical operations, in biomedical science or hospital pharmacy. You understand how the industry works. You kno
Jul 85 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