Regulatory Inspections: EDQM (Council of Europe)

The European Directorate for the Quality of Medicines & HealthCare (EDQM) is a directorate within the Council of Europe, established to protect public health by enabling, supporting, and monitoring the implementation of quality standards for medicines and healthcare across Europe and beyond. Compliance with its standards, published through the European Pharmacopoeia (Ph. Eur.), is legally required for medicines marketed in the 39 member states and the European Union.