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European Pharmacopoeia / Monograph News 14 December 2017 Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) Commission has achieved an important milestone in the field of biotherapeutic products at its 159th Session, held in Strasbourg on 21-22 November 2017, with the adoption of the monograph for Infliximab concentrated solution (2928).
European Pharmacopoeia / Animal testing News 08 December 2017 Strasbourg, France
During its 159th plenary session, held in Strasbourg on 21-22 November 2017, the European Pharmacopoeia Commission endorsed the complete suppression of the test for abnormal toxicity from the European Pharmacopoeia (Ph. Eur.).
Certification of suitability (CEP) / Procedure of certification (general) News 07 December 2017 Strasbourg, France
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.

More news

The EDQM will be closed from 22 December until 2 January 2018. Please find here the deadlines for placing orders to be dispatched in 2017.
Users of CEPs are invited to provide comments on draft monographs published in Pharmeuropa 29.4 before 31 December 2017.
Supplement 9.4 of the Ph. Eur is now available. CEP holders are invited to update their applications according to the revised monographs that will be implemented on 1 April 2018, and to follow the instructions given in the document.


27 March 2018 to 28 March 2018
20 June 2018 to 22 June 2018
Shanghai, China
09 October 2018 to 11 October 2018
Madrid, Spain
CPhI Worldwide 2018
The Vision of the EDQM
In brief
  • A Directorate of the Council of Europe created in 1964.
  • A leading organisation that protects public health by enabling the development, supporting the implementation and monitoring the application of quality standards for safe medicines and their safe use.
  • Also develops guidance and standards in the areas of blood transfusion, organ transplantation and consumer health issues.
The European Pharmacopoeia
In brief
  • Main objective is to provide common quality standards to control the quality of medicines and of substances used in the manufacture of medicines (human and veterinary use).
  • Legally binding in European member states.
  • 39 signatory countries (including the EU) and 29 observers (including WHO and TFDA) as of December 2017.
Official Medicines Control Laboratories (OMCL)
In brief
  • A network of independent public laboratories appointed by the national authorities.
  • Around 70 laboratories provide human and technical resources to implement testing programmes.
  • 36 European countries and 5 countries outside Europe participate in the various activities and programmes.
The Certification of Suitability
In brief
  • Established in 1994.

  • Over 4,200 certificates covering more than 1,000 substances have been granted in more than 50 countries.

  • Assessment is jointly performed by assessors from the national competent authorities and EDQM assessors

  • Organises an inspection programme involving a network of around 100 assessors and 30 inspectors from 24 different national competent authorities and the EDQM.

HealthCare Activities
In brief
  • Blood Transfusion & Organ Transplantation: elaborating ethical, legal and safety standards.
  • Pharmaceutical Care : developing and promoting best practices
  • Anti-counterfeiting activities: supporting the protection of public health.
  • Cosmetics & Packaging Materials: focusing on the safe use of cosmetics and packaging materials for food and medicines.
Ph. Eur.: Republic of Moldova becomes 39th Member

On 24 January 2017, the Permanent Representation of the Republic of Moldova to the Council of Europe handed to Mr Thorbjørn Jagland, Secretary General of the Council of Europe, the instrument of accession to the Convention on the Elaboration of a European Pharmacopoeia [European Treaty Series n° 050], as amended by the Protocol of 16 November 1989.
The Convention has entered into force in the Republic of Moldova on 25 April 2017, making the country the 39th Member State of the European Pharmacopoeia.

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