The quality of medicines and healthcare products in Europe is harmonized through different initiatives under the supervision of the European Council.
The European Directorate for the Quality of Medicines contributes to the access to good quality medicines and healthcare through the European Pharmacopoeia, monograph, standards development, collaboration with experts from other Member States and combat against counterfeiting.
The European Directorate for the Quality of Medicines is a Directorate of the Council of Europe (Directorate General of Democracy (DGII)). The EDQM contributes to the access to good quality medicines and healthcare through promotion and protection of human and animal health. To achieve this goal, the EDQM develops harmonized quality standard monographs through the European Pharmacopoeia and official standards to substances; it also ensures these standards are used in the production of medicines. In addition, EDQM is providing Certificates of Suitability to the monographs of the European Pharmacopoeia (CEPs). EDQM collaborates and shares expertise among Member States through the co-ordination of a network of Official Medicines Control Laboratories (OMCL). The EDQM proposes ethical, safety and quality standards through the collection, preparation, storage, distribution and appropriate use of blood components in blood transfusion and through the transplantation of organs, tissues and cells. EDQM is collaborating with national, European and international organisations in efforts to combat counterfeiting of medical products and similar crimes. Finally, EDQM also provides policies and model approaches for the safe use of medicines in Europe, including guidelines on pharmaceutical care; and by establishing standards and coordinating controls for cosmetics and food packaging.