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14/02/2022

European Directorate for the Quality of Medicines and Health Care - EDQM

The European Directorate for the Quality of Medicines and Health Care (EDQM) is a directorate of the Council of Europe. Its origins date back to 1964, when the Convention on Elaboration of a European Pharmacopoeia was adopted by the Council of Europe with the objective of creating a common European pharmacopoeia. 

The missions of the EDQM

  • establishing and providing official standards for the manufacture and quality control of medicines; 
  • ensure that these official standards are applied to drugs and their ingredients; 
  • granting Certificates of suitability which verify the compliance of pharmaceutical substances with European Pharmacopoeia standards and carrying out inspections of manufacturers of these substances
  • co-ordinating a network of Official Medicines Control Laboratories (OMCL) to collaborate and pool expertise and to effectively use limited resources with the aim of achieving effective public quality control of medicines in Europe and beyond.

The Anses-ANMV is more particularly involved in working groups linked to 2 EDQM entities: 

1-    European Pharmacopoeia Service 
2-    Biological Standardisation, OMCL Network and Healthcare Service

The Anses-ANMV is a member of the OMCL network.

1. The European Pharmacopoeia 

The European Pharmacopoeia is an official reference book used by professionals involved in the manufacture and control of medicines. Its objective is to define legally binding quality requirements for medicinal products and their ingredients. 

The European Pharmacopoeia also has a legal status in the European Union and is recognised in EU pharmaceutical legislation as setting official EU quality standards.

The texts of the European Pharmacopoeia are prepared and updated by the expert groups and working groups which meet several times a year in Strasbourg. 

The European Pharmacopoeia is widely used internationally. As globalisation and the expansion of international trade in medicines have increased the need to develop global quality standards, the Commission works closely with all Pharmacopoeia users around the world.

Members and Observers

39 Member States including France and the European Union (EU) have signed the Convention on the Development of a European Pharmacopoeia.

5 European countries, 23 non-European countries, the Taiwan Food and Drug Administration (TFDA) of the Ministry of Health and Welfare and the World Health Organisation (WHO) have observer status.

2. OMCL Network


The OMCL network (Official Medicine Control Laboratory) is composed of 70 laboratories from around 40 Council of Europe countries as well as a few observer countries that have signed the Convention for the development of the European Pharmacopoeia. They shall monitor medicinal products for human or veterinary use available on the market, independently and impartially, following the same quality benchmark (ISO17025) and in accordance with guidelines accepted by consensus. This network is coordinated by the EDQM (European Directorate of Quality of Medicines & Health Care). Some programs are strictly reserved for laboratories from EU Member States for products with European marketing authorisations. Programs, results and sometimes samples are shared to avoid duplication. They also play an important role in the control of counterfeit or falsified medicines. Control programs are generally developed using a risk analysis approach.

The Anses-ANMV laboratory is a full member of this network and is actively involved in the control of veterinary medicinal products. Every year, it participates in the control of medicinal products with a centralised MA organised by the EMA (European Medicine Agency), but also in the control of medicinal products with a marketing authorisation obtained via mutual or decentralised recognition procedures. The laboratory tests approximately 120 to 130 medicinal products per year and monitors non-compliant results. 

Two laboratories from Anses are part of the OMCL network. The Anses-ANMV in Fougères treats veterinary medicinal products and the Nancy laboratory is the official control laboratory for rabies vaccines.