Regulatory and procedural guideline: Biologics Working Party (BWP) Ad hoc Influenza Working Group - Amended European Union recommendations for the seasonal influenza vaccine composition for the season 2023/2024-2023/4/3

Regulatory and procedural guideline: Guideline on computerised systems and electronic data in clinical trials-2023/03/10

Regulatory and procedural guideline: Draft Qualification Opinion for Stride velocity 95th centile as primary endpoint in studies in ambulatory Duchenne Muscular Dystrophy-2023/03/01

Regulatory and procedural guideline: European Medicines Agency procedural advice on recommendations on unforeseen variations according to Article 5 of Commission Regulation (EC) No 1234/2008-2023/02/27

Scientific guideline: Guideline on plasmid DNA vaccines for veterinary use-2023/02/24

Regulatory and procedural guideline: Questions & Answers regarding Cannabis-derived medicinal products and the scope of EU herbal monographs for herbal medicinal products within the EU medicines legislation-2023/02/15

Regulatory and procedural guideline: Validation checklist for Type II quality variations (updated)-2023/02/10

Scientific guideline: ICH Guideline M13A on bioequivalence for immediate-release solid oral dosage forms - Step 2b-2023/02/07

ICH guideline M13A on bioequivalence for immediate-release solid oral dosage forms ICH Guideline M13A on bioequivalence for immediate-release solid oral dosage forms - Scientific guideline-2023/02/07

ICH Q9 Quality risk management - Scientific guideline (updated)-2023/02/06