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The EDQM traces its origins and statutes to a European treaty promoting the elaboration of a common pharmacopoeia in Europe.
EMA and the EDQM cooperate on matters aimed at ensuring the quality of medicines and protection of public health.
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).
For more information, see:
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.
EMA works with the EDQM in four main areas:
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, EMA-EC have signed a working arrangement with EDQM in April 2019:
The EDQM participates as an observer at Agency meetings, so that it can be aware of upcoming guidelines and marketing-authorisation applications:
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).
EMA takes part in these EDQM meetings:
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.