The European Directorate for the Quality of Medicines & HealthCare, or EDQM, is a directorate within the Council of Europe Directorate General of Democracy (DGII). The EDQM is responsible for the elaboration of legally binding quality standards for good quality medicines.
In addition, the EDQM develops guidance and standards in the areas of blood transfusion, organ, cell and tissue transplantation and consumer health.
The EDQM is headed by a Director and consists of nine entities. In its work, the EDQM relies on the network of experts of its steering committees and groups of experts.
In order to sustain its mission and guarantee high-level deliverables to its stakeholders, the EDQM operates on the basis of an ISO 9001-certified Quality Management System.
The European Pharmacopoeia Department (EPD) is responsible for the Secretariat of the European Pharmacopoeia (Ph. Eur.) Commission and for preparing the texts of the Ph. Eur. with the relevant groups of experts.
The purpose of a pharmacopoeia is to ensure that medicines are safe and of good quality. It is a single reference work for official quality standards for medicines and their components that apply throughout the entire life cycle of a product.
To elaborate the European Pharmacopoeia, the EPD works with a network of nearly 700 experts with an extensive scientific background in different disciplines and from all over Europe and beyond.
The legally binding specifications and quality control methods in the Ph. Eur. ensure the quality of medicines throughout the continent.
The Laboratory Department (DLab) supports the elaboration of the Ph. Eur. monographs by conducting analytical studies for establishing the corresponding reference standards (RSs).
The official Ph. Eur. reference standards are essential for the application of the quality control tests described in the Ph. Eur. monographs. They are needed to identify the pharmaceutical substance or product tested, determine its content or potency and control any impurities that may originate from its manufacturing process.
Reference standards can be of different types. They include chemical reference substances, herbal reference standards and biological reference preparations. A number of reference standards are established by the EDQM Laboratory with the participation of external laboratories.
The scientific expertise and the technical equipment of the EDQM Laboratory ensure that reference standards can be used by all manufacturers and independent control laboratories as a reliable means of controlling the quality of medicines and their ingredients. The Laboratory is also involved in the establishment of WHO International Standards for Antibiotics (ISA) and Chemical Reference Standards (ICRS).
The Reference Standards and Logistics Department (DRSL) is responsible for the production and distribution of Ph. Eur. reference standards and WHO International Standards for Antibiotics and International Chemical Reference Standards.
The DRSL also procures the samples analysed during the elaboration of European Pharmacopoeia monographs. It distributes reference standards to users all over the world, to both manufacturers of medicines or pharmaceutical ingredients and public institutions involved in the quality control of medicines.
Lastly, DRSL is responsible for the EDQM’s general services and its environment and safety management systems.
The Biological Standardisation, OMCL Network and HealthCare Department (DBO) is responsible for the elaboration of standards for the quality control of biologicals (Biological Standardisation Programme, or BSP). It also co-ordinates the activities of a network of official medicines control laboratories (OMCLs), independent public laboratories. The network’s main objective is to ensure the consistent quality of medicinal products for human and veterinary use on the market and to foster mutual recognition of the results of quality-control testing by OMCLs to make best use of scarce resources.
The DBO also provides the Secretariat of the European Committees on Blood Transfusion (CD-P-TS), Organ Transplantation (CD-P-TO), Pharmaceuticals and Pharmaceutical Care (CD-P-PH), Cosmetics and Consumer Health Protection (CD-P-COS), Food Contact Materials and Articles (CD-P-MCA) and their subordinate bodies.
The DBO works with around 1 200 experts.
The Certification of Substances Department (DCEP) is responsible for implementing the procedure for Certification of suitability to the monographs of the European Pharmacopoeia (CEP). The CEP procedure is one of three alternative options to demonstrate in a marketing authorisation application for a medicine that the quality of the active pharmaceutical ingredient(s) included in it is suitably controlled by the respective Ph. Eur. monograph and complies with regulatory requirements.
The DCEP is also responsible for the organisation of on-site inspections of manufacturing sites of active pharmaceutical ingredients and their follow-up, including the implementation of any subsequent action regarding the related CEPs and communication with the concerned authorities.
The DCEP works with a network of nearly 150 experts (quality assessors and inspectors nominated by national competent authorities).
The Public Relations and Documentation Division (PRDD) is responsible for the EDQM's communications with stakeholders and media in Europe and beyond. It co-ordinates all communication activities, including the EDQM website and social media, and the organisation of events.
The PRDD is also responsible for information life cycle management (archiving of paper and electronic information, documentation and digitisation projects).
The IT and Publications Division (ITPD) is responsible for the production of the EDQM publications, and for the development and maintenance of European databases such as Know-X (cold cases of falsified medicines), Melclass (classification of medicines with regard to their supply) or Frozen Bloods Units of Rare Groups (to facilitate bilateral exchanges of frozen rare blood group units for patients in need).
The Administration and Finance Division (DAF) is responsible for the administrative and financial management of the EDQM, which includes preparing and monitoring the budget, validating financial transactions and recruiting and developing staff and seconded personnel. These activities are carried out in close collaboration with the Council of Europe's Programme and Budget Directorate and the Directorate General of Administration.
The DAF is also responsible for processing customers' orders for EDQM products, issuing invoices and dealing with related queries.
The Quality and Risk Management Section (QRMS) co-ordinates the development and maintenance of the EDQM's quality and risk management systems, which aim to continuously improve EDQM products and services and ensure business continuity.
In addition, the QRMS is responsible for releasing the reference standards and samples produced at the EDQM, for classifying dangerous substances used in the preparation of reference standards, and for drafting safety data sheets.