The EDQM’s mission is to contribute to the basic human right of access to good quality medicines and healthcare and to promote and protect human and animal health.

The Directorate implements the activities under its responsibility in the Programme and Budget

Organisation chart of the European Directorate for the Quality of Medicines and HealthCare

European Pharmacopoeia Department (EPD)

  • Establishes and provides official standards which apply to the manufacture and quality control of medicines and their components in all signatory States of the "Convention on the Elaboration of a European Pharmacopoeia" and beyond
  • Ensures the translation of the European Pharmacopoeia into both official languages of the Council of Europe: English and French and the translation, proof reading and editing of EDQM texts, covering a wide range of subjects related to the activities of the EDQM

Laboratory Department (DLab)

  • Contributes to the European Pharmacopoeia by contributing to the development of analytical methods, establishes and monitors European Pharmacopoeia Reference Standards
  • Supports the WHO in the establishment of WHO International Standards for Antibiotics (ISA) and International Chemical Reference Standards (ICRS)
  • Contributes to the development of Proficiency Testing Scheme (PTS) studies for the General European OMCL Network and the World Health Organization (WHO)

Certification of Substances Division (DCEP)

  • Manages the Certification of Suitability of the monographs of the European Pharmacopoeia (CEP) procedure by evaluating requests for Certificates of suitability which verify the compliance of pharmaceutical substances with European Pharmacopoeia standards
  • Organises and carries out onsite inspections of manufacturers of these substances

Public Relations and Documentation Division (PRDD)

  • Ensures the public relations and communication activities of the EDQM, including communication with its stakeholders, the general public, the media etc., the maintenance of the website and the EDQM’s presence on social media
  • Organises EDQM events and training sessions and ensures EDQM presence in trade fairs and seminars
  • Manages the archives and the EDQM library

Quality, Safety & Environment Division (QSED)

  • Coordinates the maintenance of the EDQM's quality, safety and environmental management systems aimed to continuously improve EDQM’s products and services, including the co-ordination of the ISO certification and accreditation processes; in charge of internal Quality Audits
  • Responsible for the release of reference standards and samples produced at the EDQM, including reviewing production files before release and developing Safety Data Sheets for each Reference Standard
  • Manages the technical part of the EDQM building in cooperation with DLOG and provides support for management and improvements to the EDQM building; manages the internal mail service and the management of office supplies

Biological Standardisation, OMCL Network and Healthcare Department (DBO)

  • Co-ordinates the European network of Official Medicines Control Laboratories (OMCL) and provides the necessary tools to collaborate and share expertise among Member States and to effectively use limited resources e.g. in official control authority batch release testing of biologicals (e.g. vaccines and blood products), market surveillance studies of human and veterinary medicines and testing of suspected counterfeit medicines
  • Proposes and recommends policies on organisational (quality, safety), legal and ethical aspects for:
  • Develops practical programs such as Quality Audits and visits (External quality assessment ) and proficiency testing scheme in respect of blood banks
  • Establishes standards for cosmetics and food-contact materials and co-ordinates the network of Official Cosmetics Control Laboratories (OCCL)
  • Provides policies and model approaches for the safe use of medicines in Europe
  • Collaborates with national, European and international organisations in efforts to combat counterfeiting of medical products and similar crimes

Publications & Multimedia Department (DPM)

  • Delivery of internal IT support to EDQM staff
  • Supports implementation & maintenance EDQM-wide of IT applications
  • Provides scientific editorial support for the texts of the European Pharmacopoeia and is in charge of the publication of all the texts/publications elaborated and produced by the EDQM (including e-Publishing)

Administration & Finance Division (DAF)

  • Facilitates the effective use of EDQM financial resources, by
    • preparing and monitoring the execution of the EDQM’s budget
    • ensuring adherence to the financial regulations of the Council of Europe
    • ensuring the financial accounting for assets, stocks and income and
    • maintaining the EDQM’s cost accounting system that provides the EDQM with information on the costs of the activities it undertakes
  • Manages the order processing of EDQM products prior to shipment and responds to user and customer queries pre-and after sales; undertakes direct marketing in respect of EDQM publications
  • Oversees HR issues for EDQM; including managing and undertaking recruitment exercises, training programmes and appraisal process at the EDQM