European Directorate for the Quality of Medicines
EDQM Building, Strasbourg
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| Abbreviation | EDQM |
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| Predecessor |
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| Formation | 1964 |
| Type | Administrative entity of the Council of Europe |
| Purpose | Protection of public health |
| Headquarters | Strasbourg, France |
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Director
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Dr. Susanne Keitel |
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Staff
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Over 300 (as of October 2016) |
| 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: CETS 50, Protocol ). The signatories to the Convention – 37 member states and the European Union (EU) as of October 2016 – are committed to achieving harmonisation of the quality standards for safe medicines throughout the European continent and beyond (in addition to the member states there are 28 Observers, including WHO). The EDQM’s standards 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.
Today, direct reference is made in the EU’s pharmaceutical legislation to the European Pharmacopoeia and to other activities under the responsibility of the EDQM (e.g. the Certification procedure and the OMCL Network – see below), demonstrating the strong collaboration between the European organisations in protecting public health.
The EDQM is also involved in a number of international platforms for collaboration and harmonisation, such as the Pharmacopoeial Discussion Group (PDG), the International Generic Drug Regulators Programme (IGDRP), the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (jointly referred to as PIC/S) and the International API Inspection Programme (coordinated by the European Medicines Agency, or EMA).
In addition to the PDG, the EDQM is actively involved in a number of other international harmonisation initiatives, such as the World Health Organization (WHO) initiative to draft “Good Pharmacopoeial Practices” (GPhP), which may serve as a basis for future work-sharing and collaboration amongst pharmacopoeias worldwide. The EDQM also collaborates with WHO in a number of other ways; for example, the EDQM establishes, monitors and distributes WHO International Standards for Antibiotics (ISA) and WHO International Chemical Reference Substances (ICRS).
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