Netherlands

Draft guideline on the requirements for demonstrating therapeutic equivalence for nasal products

Clinical trial applications advice pilot becomes permanent

Quality, preclinical and clinical aspects of gene therapy medicinal products - Scientific guideline - European Medicines Agency (EMA)

Physical frailty: instruments for baseline characterisation of older populations in clinical trials - Scientific guideline - European Medicines Agency (EMA)

Medical devices legislation - European Medicines Agency (EMA)

Concept paper on the guideline revision on good pharmacogenomic practice

Clinical investigation of medicinal products in the treatment of chronic obstructive pulmonary disease (COPD) - Scientific guideline - European Medicines Agency (EMA)

ICH M11 guideline, clinical study protocol template and technical specifications - Scientific guideline - ema.europa.eu

EMA Public Declaration of Interests form - European Medicines Agency (EMA)

Clinical investigation of medicinal products in the treatment of lipid disorders - Scientific guideline - European Medicines Agency (EMA)

Expert decision and opinion in the context of the Clinical Evaluation Consultation Procedure (CECP) - European Medicines Agency (EMA)

Clinical evaluation of new vaccines - Scientific guideline - European Medicines Agency (EMA)

Non-clinical requirements for radiopharmaceuticals - Scientific guideline - European Medicines Agency (EMA)

Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials - Scientific guideline - European Medicines Agency (EMA)

Clinical development of fixed combination medicinal products - Scientific guideline - European Medicines Agency (EMA)

ICH E6 Good clinical practice - Scientific guideline - European Medicines Agency (EMA)

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28 September - 1 October