European Directorate for the Quality of Medicines

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EDQM Building, Strasbourg
The European Flag
European Directorate for the Quality of Medicines & HealthCare (EDQM)
Formed 1964
Preceding Bodies

European Pharmacopoeia (1964-1996)

European Department for the Quality of Medicines (1996-2007)
Type of Organisation Administrative entity of the Council of Europe
Location HQ Strasbourg, France
Director Dr. Susanne Keitel
Industry Public body in the field of the protection of public health
Employees 240 (as of May 2013)
Website www.edqm.eu

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 an international treaty enabling an international cooperation for the elaboration of a common pharmacopoeia in Europe (Convention on the Elaboration of a European Pharmacopoeia, CETS 50, Council of Europe in 1964,[1] Protocol [2]). In 2013, 37 member states and the European Union (EU) have signed the Convention and are committed to contributing to the protection of public health by elaborating harmonised standards to ensure the quality of medicines. The main impacts of this work are ensuring patients’ access to the same quality of medicines throughout Europe, allowing co-operation and exchange of know-how among national authorities, and hence avoiding repetition of work and unnecessary costs.

Today a direct reference to the work of the European Pharmacopoeia and to other activities under the responsibility of the EDQM (i.e. certification of suitability to the monographs of the European Pharmacopoeia and the European Network of Official Medicines Control Laboratories) is made in the EU pharmaceutical legislation, demonstrating the strong collaboration between the European organisations in the protection of public health.

In this context, the EDQM plays an essential role in the complex regulatory framework in place for medicines in Europe. Its aims are 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 standards of the European Pharmacopoeia are recognised as a scientific benchmark worldwide in the field of quality control for human and veterinary medicines. The European Pharmacopoeia is legally binding in member states under the Convention (article 1) and EU pharmaceutical legislation.[3] All medicines on the European market must comply with strict specifications on their composition and on their quality.

Similarly, the EDQM develops guidance and standards in the areas of blood transfusion, organ-, tissue- and cell transplantation, pharmaceutical care and consumer health protection.

Activities related to the Quality Control of Medicines[edit]

European Pharmacopoeia Activities[edit]

The EDQM is in charge of the secretariat of the European Pharmacopoeia (the official abbreviation is Ph. Eur.), and it does so by coordinating the elaboration of quality standards known as European Pharmacopoeia monographs for substances used in the production of medicines for human and veterinary use. When adopted, these common, harmonised quality standards are legally binding and become mandatory on the same date in the 37 Council of Europe member states who are signatory states to the European Pharmacopoeia, applying to all medicines on their markets.

The quality standards of the Ph. Eur. are used for quality control purposes during the entire life-cycle of medicines. They are elaborated collectively by experts, who come from different member states. These experts have diverse backgrounds and expertise that cover all areas related to the quality of medicines.

The governing body for the European Pharmacopoeia is the Ph. Eur. Commission, which decides on the work programme, appoints the experts responsible for preparing monographs based on nominations from the member states, and adopts the monographs (articles 6 and 7, European Pharmacopoeia Convention).[4] It meets three times a year and all technical decisions are taken by a unanimous vote.

All analytical methods described in the monographs are experimentally verified. In addition, the EDQM is also in charge of organising studies to establish the Ph. Eur. reference standards or preparations that are needed in order to carry out the tests described. There are currently over 2500 reference standards of chemical, biological or herbal origin in its collection.

The EDQM publishes a new edition of the Ph. Eur. every three years, both in English and French - the official languages of the Council of Europe. The 8th Edition, published in July 2013 is available in print and electronic versions (online and on USB key), with the online version also being accessible from mobile devices such as tablet computers and smartphones.

The Certification of suitability to the European Pharmacopeia monographs (CEP or COS)[edit]

The Certification procedure was established in 1992 as a pilot phase and turned into a routine procedure in 1994.[5] It evaluates whether the Ph. Eur. monograph(s) are suitable to effectively control the quality and the impurities linked to the specific manufacturing process of the substance in question. In addition, it provides a centralised evaluation for manufacturers of raw materials for pharmaceutical use.

In order for a manufacturer to be granted a Certificate of Suitability (CEP) that is recognised in all Ph. Eur. member states and a number of third countries around the world, and which can be used directly in the quality part of the Marketing Authorisation Application, the EDQM’s panel of assessors (who come from national medicines agencies throughout Europe) review a detailed dossier. This dossier describes the manufacturing process and the tests performed on the raw materials and the substance produced as well as necessary in-process controls. The manufacturer must demonstrate that their product complies with the quality standards required by the Ph. Eur. and European regulations and must also demonstrate the suitability of the Ph. Eur. Monograph to control the quality of their product. The applicant must also agree to comply with the relevant Good Manufacturing Practice (GMP) and to accept a site inspection at any time at the request of the EDQM.

To date, over 3600 certificates have been granted to manufacturers in more than 50 countries, covering around 850 substances. In 2012, the EDQM received 389 new applications and about 1200 applications to revise certificates that had already been granted.

Market Surveillance Programmes for Medicines (OMCL)[edit]

On 26 May 1994, the European Commission and the Council of Europe decided to establish a network of Official Medicines Control Laboratories (OMCLs) under the aegis of the EDQM, co-financed by the two partners. This was a new co-operative venture in the area of the quality control of medicines for human and veterinary use on the market.

This Network is made up of independent public laboratories, appointed by the national authorities that are responsible for controlling medicinal products on the market. The Network currently consists of 67 laboratories, or OMCLs, and the EDQM is responsible for co-ordinating the Network’s technical activities and ensuring the smooth running of the different joint programmes.

The Network performs studies on medicines already on the market (Market Surveillance Studies). The EDQM carries out inter-laboratory testing activities for OMCLs to improve their laboratory performance (Proficiency Testing Scheme studies) and promotes common quality management systems in all OMCLs to enable their work-sharing and mutual recognition of test results.

The EDQM is also the secretariat for the Official Control Authority Batch Release (OCABR) procedures of the Network for certain products (e.g. vaccines, blood- and plasma-derived products, immunological veterinary medicinal products) and in testing activities related to counterfeit medicines. The OCABR procedure guarantees that for the vast majority of for example vaccines used in the European Union, no batch of vaccine is released for marketing in member states without first undergoing an independent quality examination by a laboratory of the OMCL Network.

HealthCare Activities[edit]

The work of the EDQM in the area of blood transfusion is co-ordinated by the European Committee on Blood Transfusion. Experts from signatory states of the European Pharmacopoeia convention and observer states, as well as the European Commission and the World Health Organization (WHO), work together on the ethical, legal and organisational aspects of blood transfusion. The "Guide to the preparation, use and quality assurance of blood components" [6][7] contains recommendations on blood collection, blood components, technical procedures, transfusion practices and quality systems for blood establishments.

The EDQM is also involved in the organisation of the World Blood Donor Day, celebrated globally on 14 June every year.

The European Committee on Organ Transplantation is the steering committee in charge of transplantation activities. It actively promotes the non-commercialisation of donations, the fight against organ/tissue trafficking and the development of ethical, quality and safety standards in the field of organ, tissue and cell transplantation. An important part of their work is the elaboration of guides such as the "Guide to quality and safety of organs for transplantation" [8][9] and the "Guide to the quality and safety of tissues and cells for human application".

The EDQM organises a European Day for Organ Donation and Transplantation together with a different member state every year, to promote organ donation and transplantation in its member states.

The European Committee on Pharmaceuticals and Pharmaceutical Care [10] oversees the work programmes carried out by the different committees of experts responsible for activities related to the legal classification of medicines, pharmaceutical practices and pharmaceutical care, and prevention of counterfeit medicines and related crimes.

Since 1 January 2009, the EDQM has been engaged in efforts to strengthen consumer health protection in Europe, with a focus on the safe use and quality of cosmetics and materials designed for packaging or other purposes involving contact with foodstuffs or medicines.

The Consumer Health Protection Committee is in charge of the management of the work programme. It has two groups of experts that examine health-related matters and prepare reports and recommendations concerning regulatory approaches: the Committee of experts on packaging materials for food and pharmaceutical products and the Committee of Experts on Cosmetic Products.

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