The European Directorate for the Quality of Medicines & HealthCare (EDQM) is a directorate of the Council of Europe.
Its origins date back to 1964, when the Convention on the Elaboration of a European Pharmacopoeia was adopted by the Council of Europe, with the vision of creating a common European Pharmacopoeia.
The creation of a technical Secretariat was foreseen in the convention, and over the years it has become a directorate, with successive name changes reflecting the new missions assigned to it.
In 2021, the EDQM employs nearly 400 staff of 25 different nationalities and is composed of nine administrative entities.
The European Pharmacopoeia Department (EPD) is responsible for the Secretariat of the European Pharmacopoeia Commission and for preparing the texts of the European Pharmacopoeia (Ph. Eur.) with the relevant groups of experts.
The purpose of the Ph. Eur. is to ensure that medicines are safe and of good quality. It provides official quality standards (or monographs) for medicines and their components that are legally binding in the member states having ratified the Convention on the Elaboration of a European Pharmacopoeia and which are applied in many countries outside Europe.
To elaborate the Ph. Eur., the EPD works with a network of over 800 experts with an extensive scientific background in different disciplines and from all over Europe and beyond. They represent national authorities (e.g. pharmacopoeial authorities, official medicines control laboratories, licensing authorities, inspectorates), the private sector (pharmaceutical and chemical industries), academia or research organisations. The Ph. Eur. work programme is allocated to over 61 working groups and working parties, which hold regular meetings during the year.
The Ph. Eur. Commission, the governing body of the Ph. Eur., holds three sessions per year in order to formally adopt not only the Ph. Eur. texts, but also its work programme and to appoint Ph. Eur. experts.
The Laboratory Department (DLab) supports the elaboration and revision of the Ph. Eur. monographs with a focus on conducting analytical studies to establish the corresponding reference standards (RSs) that allow manufacturers to check whether their products meet the requirements of the Ph. Eur.
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 impurities that may originate from its manufacturing process.
The DLab is also involved in establishing WHO International Standards for Antibiotics (ISA) and Chemical Reference Standards (ICRS).
The scientific expertise and the technical equipment of the EDQM Laboratory, to which ISO 17025:2017 accreditation attests, 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 Reference Standards and Logistics Department (DRSL) is responsible for the production, storage 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 Ph. Eur. monographs. It distributes reference standards to users worldwide, to both manufacturers of medicines or pharmaceutical ingredients and public institutions involved in the quality control of medicines.
The DRSL maintains a catalogue of over 3 000 different reference standards, with nearly 30 000 samples in storage (between +5°C to –80°C) at the EDQM. The secondary site of the EDQM, inaugurated in 2019, enables the safe storage of contingency stocks of reference standards and ensures the sustainability and continuity of the supply of pharmaceutical reference standards in the event of major incidents at its main site in Strasbourg.
Lastly, DRSL is responsible for the EDQM’s general services (building facilities, furniture, mail service, etc.) and its environment and safety management systems.
The remit of the Biological Standardisation, OMCL Network and HealthCare Department (DBO) covers a broad range of areas.
The DBO co-ordinates the Biological Standardisation Programme (BSP) whose purpose is to establish reference materials and develop new analytical methods for the quality control of biologicals. This includes the development of alternative methods for the replacement of animals in the quality control of medicines.
It also co-ordinates the activities of a network of national official medicines control laboratories, the OMCL Network. As the quality of medicines is monitored throughout their entire life-cycle, it is necessary to develop independent market surveillance programmes at European level. The objective of the OMCL Network is to ensure the consistent quality of medicines for human and veterinary use 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 several steering committees in charge of the implementation of work programmes aimed at protecting public health in several different fields. This includes:
- providing legal tools and guidance to national authorities in the fight against falsified medical products;
- providing guidance to professionals concerned with pharmaceutical care by promoting knowledge, skills and values in care and practices involving medicines;
- setting specific quality standards for the correct preparation of unlicensed medicines suitable for children to support healthcare professionals;
- setting ethical, safety and quality standards for substances of human origin used in medical therapies (e.g. blood, organs, tissues and cells);
- developing standards for improving the protection of consumers in Europe, such as food-contact materials and cosmetics.
The DBO works with around 1 200 experts nominated by member states.
The Certification of Substances Department (DCEP) is responsible for implementing the procedure for Certification of suitability to the monographs of the European Pharmacopoeia.
This is a centralised procedure used to demonstrate that the quality of an active pharmaceutical ingredient is suitably controlled by the respective Ph. Eur. monograph and complies with regulatory requirements.
Certificates of Suitability (CEPs) are used by the pharmaceutical industry in their marketing authorisation applications (MAAs) for medicines and are recognised by national licensing authorities.
As part of the Certification procedure, the DCEP is also responsible for the organisation of on-site inspections of manufacturers of active pharmaceutical ingredients. Inspections ensure that substances are produced in accordance with Good Manufacturing Practices (GMPs) and that the information provided in the application dossiers is accurate. If anomalies are detected, it follows up corrective action at the site. This includes liaising with the relevant 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, public relations and information life-cycle management activities.
Communication projects are run in collaboration with the respective specialised departments. The aim is to develop and maintain communication with the EDQM’s stakeholders and media in Europe and beyond via the EDQM website, social media channels, print and electronic publications, and promotional campaigns.
The PRDD also organises a wide range of events, from conferences, training sessions and seminars to visits to the EDQM premises and, more recently, numerous online events such as webinars. It also represents the EDQM at international trade exhibitions and other events.
In managing the information life-cycle at the EDQM, PRDD maintains and develops the Electronic Document & Record Management System (EDRMS), and handles paper archives and digitisation projects. This section also manages the EDQM Library, which makes a wide variety of specialised publications and periodicals available to EDQM staff, and operates the EDQM HelpDesk, which fields questions from EDQM users year-round.
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 overseeing the budget, validating financial transactions and managing the recruitment and development of staff and seconded personnel.
The DAF prepares and monitors the EDQM budgets and validates all financial requests and processes requests for payment. It also accounts for fixed assets and stocks and calculates the costs of EDQM activities.
The DAF is also responsible for processing users’ orders for EDQM products, issuing invoices and dealing with related queries.
In terms of human resources, the DAF organises recruitment exercises and the training programme, and oversees the appraisal process for the nearly 400 EDQM staff.
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 Quality and Risk Management Section (QRMS) co-ordinates the development and maintenance of the EDQM’s quality and risk management systems, which aim to continually improve EDQM products and services and ensure business continuity. This includes maintaining an up-to-date EDQM Risk Register.
As part of the EDQM’s efforts to drive continuous improvement, the QRMS co-ordinates ISO certification and accreditation activities and performs quality audits.
In addition, the QRMS is also responsible for releasing the reference standards produced at the EDQM, for classifying dangerous substances used in the preparation of reference standards, and for drafting the necessary safety data sheets in up to 26 languages together with the corresponding leaflets.