The EDQM is the Directorate of the Council of Europe tasked with supporting public health protection. The quality standards for safe medicines it sets with its European Pharmacopoeia are recognised as a scientific benchmark world-wide and are legally binding in member states across Europe. Similarly, the EDQM develops guidance and standards in the areas of blood transfusion, organ transplantations and consumer health issues.
The European Pharmacopoeia
The European Pharmacopoeia is a single reference work for the quality control of medicines. Its purpose is to promote public health by the provision of recognised common standards for the quality of medicines and their components. Such standards are the basis for the quality of medicines used by patients in Europe. In addition, their existence facilitates the free movement of medicinal products across Europe and beyond.
The official standards published within the European Pharmacopoeia provide a legal and scientific basis for quality control during the development, production and marketing processes. They concern the qualitative and quantitative composition and the tests to be carried out on medicines, on the raw materials used in production of medicines and on the intermediates of synthesis. All producers of medicines and/or substances for pharmaceutical use must therefore apply these quality standards in order to market their products in the signatory states of the Convention.
Several legal texts make the European Pharmacopoeia mandatory, notably, the Convention developed by the Council of Europe on the Elaboration of a European Pharmacopoeia; and European Union Directives 2001/83/EC and 2001/82/EC, as amended, on medicines for human and veterinary use. These maintain the mandatory character of European Pharmacopoeia monographs when requesting marketing authorisation (MA).
The European Pharmacopoeia is widely used internationally. As globalisation and expansion in international trade present a growing need to develop global quality standards for medicines, the Commission works closely with all users of the Pharmacopoeia worldwide.