The Council of Europe (CoE) is an international organisation promoting cooperation between all countries of Europe in the areas of legal standards, human rights, democratic development, the rule of law and cultural co-operation. It was founded in 1949, has 47 member states with some 800 million citizens, and is an entirely separate body from the European Union (EU), which has 28 member states. Unlike the EU, the Council of Europe cannot make binding laws.

The best known bodies of the Council of Europe are the European Court of Human Rights, which enforces the European Convention on Human Rights, and the European Pharmacopoeia Commission, which sets the quality standards for pharmaceutical products in Europe. The Council of Europe’s work has resulted in standards, charters and conventions to facilitate cooperation between European countries.

European Directorate for the Quality of Medicines and Healthcare (EDQM)

The EDQM is an institution part of the CoE that has the mission to protect publich health by:

  • enabling the development,
  • supporting the implementation, and
  • monitoring the application

of quality standards for safe medicines and their safe use. The EDQM standards are recognised as a scientific benchmark world-wide. The European Pharmacopoeia is legally binding in member states. Similarly, the EDQM develops guidance and standards in the areas of blood transfusion, organ transplantations and consumer health issues.