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European Pharmacopoeia / International harmonisation News 14 August 2018 Strasbourg, France
The EDQM is proud to be co-sponsoring the 18th International Conference of Drug Regulatory Authorities (ICDRA) which will take place in Dublin (Ireland) from 03 to 07 September.
EDQM News 13 August 2018 Strasbourg, France
The EDQM would like to inform you that its office will be closed on Wednesday 15 August 2018 for public holiday
Certification of suitability (CEP) / Procedure of certification (general) News 13 August 2018 Strasbourg, France
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.

More news

Users of CEPs are invited to provide comments on draft monographs published in Pharmeuropa 30.3 before 30 September 2018.
The EDQM is aware of a quality defect related to an impurity in the active substance valsartan used in medicines to treat high blood pressure marketed in Europe.
This project will favour better interaction between the analytical and enforcement actors involved in the fight against falsified medicines and medical devices.

Agenda

09 October 2018 to 11 October 2018
Madrid, Spain
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 30 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 4,900 certificates covering more than 1,100 substances have been granted in more than 60 countries.
  • Assessment is jointly performed by a network of around 100 assessors from the national competent authorities and EDQM assessors.
  • Organises an inspection programme involving a network of around 30 inspectors from 20 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.
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Ph. Eur. Commission: Uzbekistan became the 30th Observer
Focus

During its March 2018 session, the Ph.Eur. Commission unanimously decided to grant Uzbekistan observer status. This brings to 30 the number of observers, from 6 continents. As observer, Uzbekistan can participate in the scientific work of the Commission and its expert meetings, attend Commission sessions and become involved in other EDQM activities. Observer status also facilitates development of a mutually-beneficial relationship and sharing of expertise on issues pertinent to the quality of medicines and healthcare.

More information on Ph. Eur. Members and observers.

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