The European Directorate for the Quality of Medicines & HealthCare (EDQM) is an agency and partial agreement of the Council of Europe that traces its origins and statutes to the Convention on the Elaboration of a European Pharmacopoeia (an international treaty adopted by the in 1964: ETS 50, Protocol).
The signatories to the convention – 39 member states and the European Union (EU) as of March 2020 – are committed to the harmonisation of quality standards for safe medicines throughout the European continent and beyond. In addition to the member states there are currently 30 observers, including the World Health Organization (WHO) and the Taiwan Food and Drug Administration (TFDA). The EDQM's quality standards for medicines are published in the European Pharmacopoeia (officially abbreviated to Ph. Eur.), which is recognised as a scientific benchmark worldwide and is legally binding in member states.
The EU pharmaceutical legislation refers directly to the Ph. Eur. and to other activities for which the EDQM is responsible (e.g. the Certification procedure or "CEP" and the OMCL Network – see below), demonstrating the shared commitment of the European organisations to public health protection.
The EDQM is also involved in a number of international collaboration and harmonisation initiatives, such as the Pharmacopoeial Discussion Group (PDG), the International Pharmaceutical Regulators Programme (IPRP), the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), the International Meeting of World Pharmacopoeias (IMWP), the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) and the International API Inspection Programme (co-ordinated by the European Medicines Agency, or EMA).
In addition, the EDQM works closely with World Health Organization (WHO) on the establishment, monitoring and distribution of WHO International Standards for Antibiotics (ISA) and WHO International Chemical Reference Substances (ICRS) which are necessary to apply the tests described in the .
The EDQM therefore plays an essential role in the complex regulatory framework for medicines in Europe. Its primary purpose is to protect public health by enabling the development, supporting the implementation and monitoring the application of quality standards for safe medicines and their safe use.
The EDQM’s mission Within the Council of Europe, the EDQM's mission is to contribute to the basic human right of access to good quality medicines and healthcare, and to promote and protect human and animal health by: establishing and providing official standards for the manufacture and quality control of medicines in all the signatory states of the Convention on the Elaboration of a European Pharmacopoeia, and beyond; granting Certificates of suitability to manufacturers whose pharmaceutical substances comply with Ph. Eur. standards, and carrying out inspections of the manufacturing sites concerned; co-ordinating a network of Official Medicines Control Laboratories (OMCLs) to collaborate and share expertise between member states and optimise the use of available resources, with the aim of achieving effective independent quality control of medicines in Europe and beyond; proposing ethical, safety and quality standards for blood transfusions (collection, preparation, storage, distribution and appropriate use of blood components) and the transplantation of organs, tissues and cells; working with national, European and international organisations in the fight against falsification of medical products and similar crimes; providing policies and model approaches for the safe use of medicines in Europe, including guidelines on pharmaceutical care; and establishing standards for cosmetics and food contact materials and articles, and co-ordinating the independent control of cosmetics.
Leadership Directors: Petra Dörr (as of 1 October 2021) Susanne Keitel (1 October 2007 – 30 September 2021) Agnès Artiges (1994 – 31 July 2007)
Activities related to the quality of medicines
The European Pharmacopoeia: setting quality standards for Europe and beyond and supplying pharmaceutical reference standards
Published and regularly updated by the EDQM or Council of Europe in English and French, the two official languages of the , the Ph. Eur. is a compendium of official quality standards for medicines and their ingredients. It thus helps define the requirements to be met by manufacturers seeking to obtain marketing authorisation (MA) for a (human or veterinary) medicinal product in Europe, but its standards are also recognised and used worldwide as a scientific benchmark in the field of quality control for human and veterinary medicines.
These common harmonised quality standards – known as monographs – describe strict specifications for medicines and the substances used in their manufacture, that apply throughout the product's entire life cycle. When adopted, they are legally binding and become mandatory on the same date in the 39 European countries that are signatories to the Ph. Eur. convention, applying to all medicines on their markets.
The contents of the Ph. Eur. are elaborated and updated by the Ph. Eur. Commission, which is responsible for overseeing the practical work of more than 800 experts in every field of the pharmaceutical sciences – all volunteers – who participate in currently 61 groups of experts and working parties. The Ph. Eur. Commission decides on the work programme, appoints the experts and adopts the monographs and other texts that comprise the Ph. Eur. (Articles 6 and 7, Ph. Eur. convention. It meets three times a year in Strasbourg (France) and takes all technical decisions by a unanimous vote. The EDQM provides the scientific secretariat and logistical support for the work of the Ph. Eur. Commission, and facilitates the activities of its groups of experts and working parties.
The texts of the Ph. Eur. cover all therapeutic areas and comprise: individual monographs describing legally binding quality standards for medicines and the ingredients used in their manufacture (active ingredients, excipients, herbals, etc.); individual monographs describing legally binding quality standards for medicinal products; general monographs describing legally binding quality standards for classes of substances (such as fermentation products or substances for pharmaceutical use) or for the different dosage forms that medicines can take (tablets, capsules, injections, etc.); and, general methods of analysis for substances used in the manufacture of medicines, which are not legally binding and may also be used for substances and medicines not described in the Ph. Eur.
All the analytical methods described in the monographs are experimentally verified. In addition, the EDQM is responsible for establishing and supplying the official reference standards without which it would be impossible to carry out many of the mandatory quality control tests described in the Ph. Eur. These physical standards are used by manufacturers located both in Europe and around the world, and national and European authorities involved in the quality control of medicines, to name but a few. The EDQM publishes a new edition of the Ph. Eur. every three years.
The current chair of the commission is professor Salvador Cañigueral, who was elected in March 2022.EDQM, Ph. Eur. Commission elects its new Chair at 172nd Session, www.edqm.eu, 8 April 2022
The Certification procedure: evaluating the quality of active ingredients and excipients and inspecting manufacturing sites
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The EDQM runs a quality evaluation programme for active ingredients and excipients used in the manufacture of medicines. The Certification of Suitability to the Monographs of the European Pharmacopoeia procedure was initially set up in 1992 as a pilot programme but went on to become routine for chemical substances in 1994; it was expanded in 2003 to include herbal drugs (active substances obtained from plants)."Resolution AP-CSP (07) 1 (adopted by the Public Health Committee (Partial Agreement) (CD-P-SP) on 21/02/2007) Certification of suitability to the monographs of the European Pharmacopoeia (revised version)s" Granted after an assessment of the documentation submitted by the applicant, a Certificate of Suitability (CEP) provides proof that the methods used by a manufacturer or distributor result in a product whose quality complies with the requirements laid down in the corresponding Ph. Eur. monograph(s). The EDQM also runs an inspection programme for CEP-holders, targeting their manufacturing and/or distribution sites.
The Certification procedure is not compulsory: it is a service that is offered to manufacturers who can submit their CEP in the quality section of a new marketing authorisation application or a variation of an existing marketing authorisation. It serves to centralise the evaluation of data for the benefit of both regulatory authorities and industry, thus saving time and resources.
A further advantage of the Certification procedure is that it provides the Ph. Eur. Commission with up-to-date information on the quality of substances on the European market, highlighting where Ph. Eur. texts and quality requirements might require revision and helping to ensure that the pharmacopoeia remains state-of-the-art.
CEPs – which are referred to in EU pharmaceutical legislation – are accepted by the Ph. Eur. member states and by a number of other countries and regions, including Australia, Canada, New Zealand, Saudi Arabia, Singapore, South Africa, Taiwan and Tunisia. An increasing number of licensing authorities worldwide accept CEPs to support (fully or partially) the data related to the quality of active ingredients used in medicinal products.
As previously stated, a CEP is granted after members of the EDQM's panel of assessors (drawn from national medicines agencies throughout Europe) have reviewed a detailed dossier submitted by the manufacturer. This dossier describes the manufacturing process and the tests performed on the raw materials and on the substance produced, as well as the necessary in-process controls. The manufacturer must demonstrate that the article complies with the quality standards laid down in Ph. Eur. and the EU legislation and that the monograph can be used to control impurities, unwanted chemicals that can be present in a substance for a variety of reasons. The applicant must also agree to comply with the relevant EU good manufacturing practice guidelines (GMP guide) as defined in Part II of the GMP Guide,"Guidance on good manufacturing practice and good distribution practice: Questions and answers" and to accept an on site inspection at any time at the request of the EDQM.
The OMCL network: quality control of medicines on the market
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On 26 May 1994, the European Commission and the Council of Europe decided to launch a new, jointly funded, co-operative venture targeting the quality control of medicines for human and veterinary use on the market, called the European Network of Official Medicines Control Laboratories (OMCLs). Open to both member states and observers of the Ph. Eur. convention, this network is made up of independent public laboratories that have been appointed by their respective national authorities. Their primary mission is to ensure, through random sample testing, that medicines supplied to patients – wherever they are in Europe – comply with the applicable quality standards and the terms and conditions of their MA.
The laboratories that form the network share resources, expertise and workloads: this not only contributes to reducing public health expenditure, a broader coverage of medicines on the market and to the development of future harmonised common standards, but means that laboratories across Europe have access to state-of-the-art technology and selective analytical procedures.