European Directorate for the Quality of Medicines & HealthCare
Abbreviation | EDQM |
---|---|
Predecessor |
|
Formation | 1964 |
Type | Administrative entity of the Council of Europe |
Purpose | Protection of public health |
Headquarters | Strasbourg, France |
Director | Petra Dörr |
Staff | Over 340 (as of February 2020[update]) |
Website | www |
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is a Directorate 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 Council of Europe in 1964: ETS 50,[2] Protocol[3]).
The signatories to the convention,
The EU pharmaceutical legislation refers directly to the
The EDQM is also involved in a number of international collaboration and harmonisation initiatives, such as the Pharmacopoeial Discussion Group (PDG),[5] the International Pharmaceutical Regulators Programme (IPRP), the International Council for Harmonization 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[6] (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)[7] and WHO International Chemical Reference Substances (ICRS)[8] which are necessary to apply the tests described in the WHO International Pharmacopoeia.
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,[2] 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)[9]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)[10] and the transplantation of organs, tissues and cells;[11]
- working with national, European and international organisations in the fight against falsification of medical products and similar crimes;[12]
- 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)[13]
- Susanne Keitel (1 October 2007 – 30 September 2021)
- Agnès Artiges (1994 – 31 July 2007)
The European Pharmacopoeia: setting quality standards for Europe and beyond and supplying pharmaceutical reference standards
Published and regularly updated by the EDQM/
These common harmonised quality standards – known as
The contents of the
The texts of the
- individual 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 , 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
The current chair of the commission is professor Salvador Cañigueral, who was elected in March 2022.[16]
The Certification procedure: evaluating the quality of excipients and inspecting manufacturing sites
Source:[17]
The EDQM runs a quality evaluation programme for
The Certification procedure[17] is not compulsory: it is a service that is offered to manufacturers who can submit their CEP[18] in the quality section of a new marketing authorisation (MA) application or a variation of an existing MA. 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
CEPs[18] – which are referred to in EU pharmaceutical legislation – are accepted by the Ph. Eur. member states[4] 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[18] to support (fully or partially) the data related to the quality of active ingredients used in medicinal products.
As previously stated, a CEP
The OMCL Network: quality control of medicines on the market
Source:[9]
On 26 May 1994, the
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.
Nowadays many laboratories within the network have seen a significant shift from medicines on the market testing to the analysis of falsified and illegal medicines on behalf of other authorities such as customs, police, enforcement/food inspectors and courts.
The EDQM is responsible for co-ordinating the network's technical activities and ensuring the smooth running of its various joint programmes.
The OMCL Network[9] performs studies on medicinal products already on the market (market surveillance studies). The EDQM organises inter-laboratory testing activities for OMCLs[9] to improve their analytical performance (proficiency testing scheme [PTS][21] studies and promotes common quality management systems in all OMCLs[9] to enable work-sharing and mutual recognition of test results.
The EDQM also provides the technical secretariat for the Official Control Authority Batch Release (OCABR)[22] procedures for human and veterinary immunological medicinal products (e.g. vaccines) and human blood-derived medicinal products (e.g. clotting factor, immunoglobulin, albumin. For example, the OCABR[22] procedure guarantees that for the vast majority of the vaccines used in the EU, no batch of vaccine is released to the market in member states without first undergoing an independent quality control by a laboratory of the OMCL Network[9] in addition to the release test conducted by the manufacturer.
Pharmaceutical care and combating falsified medical products
According to WHO,
In order to face this challenge while taking into account current constraints on public health budgets and social inequality in access to healthcare, the European Committee on Pharmaceuticals and Pharmaceutical Care (CD-P-PH),[24] which is co-ordinated by the EDQM, oversees the work of experts in three main areas:
- The classification of medicines authorised in Europe into prescription and non-prescription medicines: although the responsibility for classifying medicines lies with the individual member state, the CD-P-PH issues classification recommendations. These recommendations may also cover medicines that are not licensed for use in the EU, since the EDQM has a broader membership and CD-P-PH members include representatives of member states that are not part of the EU. The recommendations are updated annually and published on the EDQM's website. The EDQM also hosts the publicly available Melclass database,[25]which presents the classification status of medicines in Ph. Eur. member states.
- Setting quality and safety standards in pharmaceutical practices and pharmaceutical care: public authorities and the pharmaceutical industry devote much of their resources to ensuring the quality, safety and efficacy of medicines. However, the best treatment outcomes are only achieved when medicines are used safely and appropriately. The CD-P-PH develops scientific indicators to measure the quality of pharmaceutical care in Europe, a concept defined as "the responsible provision of drug therapy for the purpose of achieving definite outcomes that improve a patient’s quality of life". The indicators developed by the EDQM provide practical information that is of use to policymakers and professional associations on a daily basis, helping to make healthcare systems more responsible and cost-effective.
- Preventing and managing risks posed by falsified medical products: falsified medical products pose a growing and real threat to public health in Europe and world-wide. Falsified medicines and medical devices may contain poor quality ingredients, the wrong dosage of an active substance, a different active substance or even a poisonous substance, they may be deliberately mislabelled or have fake packaging or ingredients. To combat this problem, the Council of Europe established the MEDICRIME Convention (CETS No. 211),[12] the first international treaty to criminalise the falsification of medical products and similar crimes with a view to protecting public health. The convention entered into force on 1 January 2016.
Blood transfusion
The work of the EDQM in the area of blood transfusion is co-ordinated by the European Committee on Blood Transfusion (CD-P-TS),
Through its Blood Proficiency Testing Scheme[29] and Blood Quality Management Programme[30] the committee helps Council of Europe member states improve their blood transfusion services, ensuring the transfer of knowledge and expertise through training and networking and the monitoring of practices in Europe. They also assess epidemiological risks, in particular those related to the emergence of new infectious agents transmissible by blood transfusion.
Organ, tissue and cell transplantation
The work of the Council of Europe in the area of organ, tissue and cell transplantation began in 1987. The guiding principles for the EDQM's activities in this area are ensuring human dignity, maintaining and fulfilling human rights and fundamental freedoms, non-commercialisation of substances of human origin and protecting donors and recipients of organs, tissues and cells. This latter principle is fulfilled by improving and promoting strict standards for quality and safety in order to protect not only the donor and recipient, but also the precious donated organ/tissue itself.
The European Committee on Organ Transplantation (CD-P-TO)
The EDQM organises a European Donation Day (EDD)[33] together with a different member state every year, to raise awareness of the importance of organ donation and transplantation in its member states and to encourage public debate and reflection on this life-saving therapy.
Cosmetics and food contact materials
Since 1 January 2009, the EDQM has worked on strengthening consumer health protection in Europe, with a focus on the safe use and quality of cosmetics and materials and articles in contact with foodstuffs.
The European Committee on Cosmetics and Consumer Health (CD-P-COS)[34] is tasked with responding to emerging risks for health arising from the use of cosmetics. By promoting the principles laid down in Council of Europe Resolution ResAP(2008)1 on requirements and criteria for the safety of tattoos and permanent make-up,[35] the committee also works to ensure the safety of these products. Activities on the work programme focus on fostering collaboration between member states and observers.
The CD-P-COS[34] oversees the European Network of Official Cosmetics Control Laboratories (OCCLs).[36] This network was established in 2010 to maximise the efficiency of cosmetics surveillance by strengthening cross-border collaboration and pooling resources to perform Europe-wide market surveillance studies. Several control laboratories in Asia also take part.
In addition to market surveillance studies, network activities include analytical development, PTS studies and the implementation of harmonised quality management systems. Priority is given to testing products that may present a health risk for consumers, either linked to the presence of prohibited or restricted substances (according to EU legislation) or trace metals. The network also publishes test methods after performing inter-laboratory trials to confirm that these methods are fit for purpose.
The European Committee for Food Contact Materials and Articles (CD-P-MCA)[37] is tasked with developing and strengthening harmonised measures that supplement EU and national legislation to ensure the safety of packaging, containers, utensils and other materials and articles for food contact. It is supported by two subordinate bodies: the working group on food contact materials made from paper and board and the working group on printed food contact materials. The technical guides published by the CD-P-MCA[37] are used as reference documents by manufacturers and other business operators, safety evaluators and control laboratories.
References
- ^ EDQM. "History". edqm.eu.
- ^ a b c d e f Council of Europe. "Convention on the Elaboration of a European Pharmacopoeia, ETS No. 50". Council of Europe Treaty Office.
- ^ Council of Europe. "Protocol to the Convention on the Elaboration of a European Pharmacopoeia, ETS No. 134". Council of Europe Treaty Office.
- ^ a b c d e EDQM. "List of Ph. Eur. Members & Observers". edqm.eu. Archived from the original on 20 December 2021. Retrieved 11 August 2020.
- ^ EDQM. "International harmonisation". edqm.eu.
- ^ EDQM. "International API Inspection Programme". edqm.eu.
- ^ EDQM. "WHO International Standards for Antibiotics (ISA) : Purpose & Use". edqm.eu.
- ^ EDQM. "WHO International Chemical Reference Substances (ICRS) : Purposes & Use". edqm.eu.
- ^ a b c d e f g EDQM. "General European OMCL Network (GEON)". edqm.eu.
- ^ EDQM. "European Committee on Blood Transfusion (Steering Committee) (CD-P-TS)". edqm.eu.
- ^ EDQM. "European Committee on Organ Transplantation (CD-P-TO)". edqm.eu.
- ^ a b Council of Europe. "Council of Europe Convention on the Counterfeiting of Medical Products, CETS No. 211". Council of Europe Treaty Office.
- ^ "The Council of Europe appoints future EDQM Director | EDQM – European Directorate for the Quality of Medicines". edqm.eu. Retrieved 15 September 2021.
- ^ a b c d EDQM. "The European Pharmacopoeia Commission". edqm.eu. Retrieved 19 January 2021.
- ^ EDQM. "Work Programme for the European Pharmacopoeia". edqm.eu. Retrieved 19 January 2021.
- ^ EDQM, Ph. Eur. Commission elects its new Chair at 172nd Session, www.edqm.eu, 8 April 2022
- ^ a b c EDQM. "Certification Policy Documents & Guidelines". edqm.eu.
- ^ a b c d e f EDQM. "Certification of Suitability to the monographs of the European Pharmacopoeia – Background & Legal Framework". edqm.eu. Retrieved 19 January 2021.
- ^ "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"
- ^ "Guidance on good manufacturing practice and good distribution practice: Questions and answers"
- ^ EDQM. "Physico-chemical and Biological PTS". edqm.eu. Retrieved 19 January 2021.
- ^ a b EDQM. "Batch Release for Human Biologicals: vaccines, blood and plasma derivatives". edqm.eu. Retrieved 19 January 2021.
- ^ WHO. "Promoting rational use of medicines". who.int. Retrieved 19 January 2021.
- ^ "Mandate of the European Committee on Pharmaceuticals and Pharmaceutical Care (CD-P-PH)"
- ^ "Melclass Database"
- ^ "Terms of reference of the European Committee on Blood Transfusion (CD-P-TS)"
- ^ Council of Europe. "Committee on Bioethics (DH-BIO)". coe.int. Retrieved 19 January 2021.
- ^ EDQM (2020). "Guide to the preparation, use and quality assurance of blood components, 20th edn". edqm.eu. Retrieved 19 January 2021.
- ^ EDQM. "Blood Proficiency Testing Scheme (B-PTS)". edqm.eu. Retrieved 19 January 2021.
- ^ EDQM. "Blood Quality Management Programme (B-QM)". edqm.eu. Retrieved 19 January 2021.
- ^ "European Committee on Organ Transplantation (CD-P-TO)"
- ^ a b EDQM. "Organs, Tissues and Cells – Technical Guides". edqm.eu. Retrieved 19 January 2021.
- ^ "European Donation Day (EDD) – European Directorate for the Quality of Medicines & HealthCare – EDQM". European Directorate for the Quality of Medicines & HealthCare. Retrieved 24 October 2023.
- ^ a b "Terms of Reference of the European Committee for Cosmetics and Consumer Health"
- ^ Council of Europe, Committee of Ministers (20 February 2008). "Resolution ResAP(2008)1 on requirements and criteria for the safety of tattoos and permanent make-up (superseding Resolution ResAP(2003)2 on tattoos and permanent make-up)". coe.int. Retrieved 19 January 2021.
- ^ EDQM. "The Network of Official Cosmetics Control Laboratories (OCCLs)". edqm.eu. Retrieved 19 January 2021.
- ^ a b EDQM. "Terms of reference for the European Committee for Food Contact Materials and Articles (CD-P-MCA)". coe.int. Retrieved 19 January 2021.