EDQM

The European Directorate for the Quality of Medicines & HealthCare (EDQM) provides a harmonized legal and scientific framework that supports medicine makers worldwide in meeting stringent European quality standards. Access to European pharmacopoeial standards For manufacturers, the EDQM's European Pharmacopoeia (Ph.Eur.) is indispensable. It outlines the quality requirements that must be met by medicines and is legally binding in 39 countries. The Ph.Eur. offers digital editions with exclusive resources, ensuring easy access to crucial information for European markets. From its 12th edition that will be launched at the end of June, the Ph.Eur. will only be available in an online format. Streamline your regulatory process for the European market The EDQM also offers Certificates of Suitability to the Monographs of the European Pharmacopoeia (CEPs), which streamline regulatory processes by replacing data in the quality section of Marketing Authorisation Dossiers. CEPs are recognized in all Ph.Eur. member states and beyond, simplifying the path to regulatory approval for active substances, excipients, and herbal products. Reference standards – essential for compliance Moreover, the EDQM provides official reference standards for over 3,000 substances, essential for verifying compliance with the Ph.Eur. These standards are shipped worldwide, ensuring that manufacturers can consistently meet the legal requirements of the European Pharmacopoeia. The EDQM is part of the Council of Europe and promotes a world in which everyone can enjoy better health. More about the EDQM: www.edqm.eu