The Scientific Advice Working Party (SAWP) within the European Medicines Agency (EMA) provides scientific advice and protocol assistance to companies developing medicines. The SAWP was established by the EMA’s Committee for Medicinal Products for Human Use (CHMP).
It is a multi-disciplinary group with expertise in non-clinical safety, pharmacokinetics, methodology and statistics, and in therapeutic fields for which there are frequent requests or other specific fields such as cardiology, oncology, diabetes, neurodegenerative disorders and infectious diseases including human-immunodeficiency-virus (HIV) infection. Membership includes representatives from the Committee for Orphan Medicinal Products (COMP), the Paediatric Committee (PDCO), and the Committee for Advanced Therapies (CAT).
The SAWP develops integrated views on quality relating to the development of medicines; non-clinical and clinical safety and efficacy relating to the development of medicines; and the significant benefit of orphan medicines.