Quality Standards

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 an international treaty enabling an international cooperation for the elaboration of a common pharmacopoeia in Europe (Convention on the Elaboration of a European Pharmacopoeia, CETS 50, Council of Europe in 1964, Protocol). In 2013, 37 member states and the European Union (EU) have signed the Convention and are committed to contributing to the protection of public health by elaborating harmonised standards to ensure the quality of medicines. The main impacts of this work are ensuring patients’ access to the same quality of medicines throughout Europe, allowing co-operation and exchange of know-how among national authorities, and hence avoiding repetition of work and unnecessary costs.

Today a direct reference to the work of the European Pharmacopoeia and to other activities under the responsibility of the EDQM (i.e. certification of suitability to the monographs of the European Pharmacopoeia and the European Network of Official Medicines Control Laboratories) is made in the EU pharmaceutical legislation, demonstrating the strong collaboration between the European organisations in the protection of public health.

In this context, the EDQM plays an essential role in the complex regulatory framework in place for medicines in Europe. Its aims are to protect public health by enabling the development, supporting the implementation, and monitoring the application of quality standards for safe medicines and their safe use.

The standards of the European Pharmacopoeia are recognised as a scientific benchmark worldwide in the field of quality control for human and veterinary medicines. The European Pharmacopoeia is legally binding in member states under the Convention (article 1) and EU pharmaceutical legislation. All medicines on the European market must comply with strict specifications on their composition and on their quality.

Similarly, the EDQM develops guidance and standards in the areas of blood transfusion, organ-, tissue- and cell transplantation, pharmaceutical care and consumer health protection.

It is the position of the EFNR to actively support procedure that enhance and improve general quality standards in all aspects of medicine.