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European Pharmacopoeia / General News 05 June 2020 Strasbourg, France
The EDQM is committed to supporting vaccine developers during the coronavirus disease (COVID-19) pandemic – as well as contributing to the wider global effort to combat the virus – by openly sharing knowledge and offering temporary free access to relevant guidance and standards.
Reference Standard / Collection & Catalogue News 04 June 2020 Strasbourg, France
The EDQM announces the availability of 7 new Ph. Eur. reference standards and 14 replacement batches for Ph. Eur. reference standards in May 2020.
European network of OMCLs News 28 May 2020 Strasbourg, France
The annual meeting of the European Network of Official Medicines Control Laboratories (OMCLs) took place from 12 to 15 May 2020, online and with a reduced programme due to the COVID-19 crisis. It was attended by more than 350 participants from 39 countries and was organised by the...

More news

The new edition of the Technical Guide for the elaboration and use of monographs for immunological veterinary medicinal products (2020) was approved by the European Pharmacopoeia (Ph. Eur.) Commission at its 166th session.
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.
The 2021 subscriptions to the European Pharmacopoeia Supplements 10.3-10.5 are now available on the EDQM WebStore. Two subscription formats are available: 1. Electronic version (access until 31 December 2021 - bilingual English and...

Agenda

07 July 2020 to 08 July 2020
Strasbourg, France
29 September 2020 to 01 October 2020
Strasbourg, France
10 October 2020
Strasbourg, France
Nitrosamine contamination in brief
In brief

In 2018, certain types of nitrosamines (N‑nitrosodiethylamine (NDEA) and N-nitrosodimethylamine (NDMA)) were detected in a number of active substances used in the treatment of hypertension and in related medicines. Nitrosamines are known as possible carcinogens for humans: only very low amounts are acceptable according to current regulatory requirements (ICH M7 “cohort of concern”). Their detection requires highly sensitive analytical methods. As clarified by the European Medicines Agency (EMA), their presence in active substances may be linked to several factors, e.g. from processing conditions to accidental introduction due to cross-contamination (from processes running in parallel on the same production lines) or recovery procedures for solvents, or also from degradation of the substances.

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 parties (including the EU) and 30 observers (including WHO and TFDA) as of March 2018.
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.

 

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COVID-19 pandemic: The EDQM’s contributions to the...
Focus

The EDQM’s core activities include the provision of documentary and physical (reference) standards to ensure the quality of medicines and their ingredients. Availability of and access for patients to quality medicines is more important than ever in the context of the current COVID-19 pandemic. This is why the EDQM is working hard to ensure continuous supply of our goods and services and is engaging with all stakeholders, including national, European and international authorities, to help protect public health.

 

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