Roles of the European Directorate for the Quality of Medicines (EDQM) and the European Pharmacopoeia (EP) Commission in the medicines regulations system

The EDQM houses the European Pharmacopoeia Commission. The Commission is responsible for the work on monographs and general chapters of the pharmacopoeia. The practical work is performed by a number of expert groups. The EDQM and the Commission work under the Council of Europe. The Council of Europe consists of not only the EU member states:

  • A total of 47 countries are members.
  • Out of these, 37 countries are signatory to the Convention on the Elaboration of a European Pharmacopoeia.
  • In addition, 24 European and non-European countries participate as observers.

The EU also holds a membership in the EP Commission and the European Pharmacopoeia has legal status in the EU. The EP is acknowledged in the EU directives as establishing the official quality standards of the EU.

Figure 3: In 1992, the European Directorate for the Quality of Medicines (EDQM) initiated the concept of submitting an application for Certificate(s) of Suitability to the monographs of the European Pharmacopoeia (CEPs)

The EDQM has established a concept named Certificate of Suitability (CEP) (shown in Figure 3). A manufacturer of an active substance may apply to the EDQM for such a certificate. The application should contain a full description of the chemical synthesis of the substance. A thorough discussion on potential and actual impurities should also be included. If the manufacturer can show that the quality of a substance is controlled according to the EP monograph (plus additional tests if needed), the EDQM will grant a CEP. A pharmaceutical manufacturer using that active substance in their medicine may use such a certificate. The CEP is included in the dossier for the Marketing Authorisation Application (MAA) and is deemed to replace the relevant data of the corresponding sections described in the respective Common Technical Document (CTD) module. The regulatory authorities will accept the CEP as sufficient documentation to ensure that the quality of the substance is within the ranges required. It does not replace a certificate of analysis neither is it a GMP (Good Manufacturing Practice) certificate.

The EDQM also has a role in the analytical control of medicines on the European market. A network of Official Medicinal Control Laboratories (OMCL) is coordinated by the EDQM. The OMCL are responsible for performing analytical controls of medicines on their markets. Many medicines are on the market in a large number of European countries. The OMCL network coordinates the official supervision so that the laboratory resources can be optimised. This way, the duplication of controls for the same product by several OMCLs can be avoided.