European Directorate for the Quality of Medicines and HealthCare (EDQM) of the Council of Europe
Compliance and inspectionsMedicines
The European Medicines Agency (EMA) works with the European Directorate for the Quality of Medicines and HealthCare (EDQM), a directorate of the Council of Europe. The EDQM traces its origins and statutes to a European treaty promoting the elaboration of a common pharmacopoeia in Europe. The EMA and the EDQM cooperate on matters aimed at ensuring the quality of medicines and protection of public health.
Council of Europe
The Council of Europe is an international organisation established in 1949, which today has 47 member states. Its main aim is to create a common democratic and legal area throughout the European continent, ensuring respect of its fundamental values of human rights, democracy and the rule of law.
While the Council of Europe is distinct from the European Union (EU) and its institutions, the two organisations collaborate in many areas.
The Council of Europe has a number of institutions and directorates, including the European Court of Human Rights and the European Directorate for the Quality of Medicines and Healthcare (EDQM).
European Directorate for the Quality of Medicines and Healthcare
The EDQM is an organisation that protects public health by enabling the development, supporting the implementation and monitoring the application of quality standards for medicines and their safe use.
These standards are recognised as a scientific benchmark world-wide.
The European Pharmacopoeia provides a legal and scientific reference for the quality control of medicines. It has 39 member states and 28 observers of which 5 are European countries and 23 are non-European countries. The Taiwan Food and Drug Administration (TFDA) of the Ministry of Health and Welfare and the World Health Organization (WHO) are also observers. For more information, see Membership & Observership
All producers of medicines and substances for pharmaceutical use must apply these quality standards in order to market their products in the signatory states of the Convention. This means that companies must follow these standards when applying to the EMA and include reference to the monographs in the quality part of their applications.
The EDQM also develops guidance and standards in areas such as blood transfusion, organ transplantation and consumer health issues.
Today, EU pharmaceutical legislation makes direct reference to the European Pharmacopoeia and other activities under EDQM responsibility, such as certification of suitability to the monographs of the European Pharmacopoeia and co-ordination of the European network of Official Medicines Control Laboratories. This demonstraties the close cooperation between these European organisations in the protection of public health.
Interactions between the Agency and the EDQM
The Agency works with the EDQM in four main areas:
- The Agency's quality-related working parties, such as the Quality Working Party and Biologics Working Party, regularly interact with the European Pharmacopoeia Commission and its scientific groups during the development and revision of standards. The Agency forms part of the EU delegation at European Pharmacopoeia Commission meetings and other committees related to the work of the EDQM, e.g. the certification steering committee. It also participates as an observer in meetings of scientific groups related to the Pharmacopoeia. Likewise, the EDQM participates in meetings of the quality-related working parties and committees of the Agency.
- Companies making applications to the Agency can apply to the EDQM for a certificate of suitability to confirm compliance with European Pharmacopoeia monographs for their medicines' components. These certificates cover their chemical purity, microbiological quality and/or steps necessary to reduce the risk of transmission of spongiform encephalopathies (TSE). The certificates can form part of the application dossiers submitted to the Agency as part of marketing-authorisation applications.
- The Agency supports and recognises the EDQM's work in developing standard terms for use in marketing-authorisation applications and in the product information, to ensure that the wording used is standardised across medicines and can be easily understood by the target audience, such as patients and prescribers.
- The Agency implements an annual sampling and testing programme for centrally authorised medicines as part of its responsibility for coordinating the supervision of these medicines. It does this by using the European network of Official Medicines Control Laboratories, which carry out independent retesting of medicines based on the legal requirements. The EDQM is the technical secretariat of this network and coordinates the sampling, testing and reporting. For more information, see sampling and testing.
The Agency and the EDQM hold a joint forum three or four times a year. This forum aims to develop their strategies in the areas of common interest.
More information is available in:
In addition, EC/EMA have signed a confidentiality arrangement with EDQM in April 2019.
Participation of the EDQM at Agency meetings
The EDQM participates as an observer at Agency meetings, so that it can be aware of upcoming guidelines and marketing-authorisation applications:
- Quality Working Party;
- Quality by design;
- Biologics Working Party;
- Good Manufacturing Practice / Good Distribution Practice Inspectors Working Group;
- Vaccines Working Party;
- Immunologicals Working Party (veterinary).
The Agency's Management Board has also granted the EDQM observer status at the Committee for Advanced Therapies (CAT) and the Committee on Herbal Medicinal Products (HMPC).
Participation of the Agency at EDQM meetings
The Agency takes part in these EDQM meetings:
- European Pharmacopoeia Commission;
- Certification Steering Committee;
- Sampling and Testing Steering Committee;
- Biological Standardisation Programme Steering Committee;
In addition, the Agency has been granted observer status at the European Pharmacopoeia Commission's Groups of Experts and Working Parties, e.g. groups 6B and 15, and the different advisory groups of the European network of Official Medicines Control Laboratories.