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Latest Regulatory Affairs News 2026 🔷

Introduction to Regulatory Affairs Course

Are you looking for an entry level role in regulatory affairs? Gain work experience in regulatory affairs even if you are new to this field. This is the most comprehensive introductory regulatory affairs course available, providing you with a strong foundation in regulatory affairs by increasing your baseline knowledge, as well as offering you the hard to get real work experience to enhance your skills and job search support to secure a career in regulatory affairs. The compr

Feb 3, 20249 min read

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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

Regulatory Affairs Insights

4 days ago12 min read

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Regulatory Affairs Guides

Introduction to Regulatory Affairs Course

Revising EU GMP Annex 15: What the Concept Paper Means for the Industry

How to Turn No Experience Into a Winning Regulatory Affairs CV: Your Complete Guide to Breaking Into the Regulatory Affairs

Introduction to Regulatory Affairs Course

10 Clinical Trials to Watch in H2 2026: From Lung Cancer Immunotherapy to Personalised Cancer Vaccines — A Regulatory Affairs Briefing

Guiding Principles of Good AI Practice in Drug Development: What Every Regulatory Professional Needs to Know

How to Move from Pharmaceutical Scientist to Regulatory Affairs

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