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Certification of suitability (CEP) / Procedure of certification (general) News 24 September 2021 Strasbourg, France
From the beginning of October 2021, the CEP Department (DCEP) of the European Directorate for the Quality of Medicines & HealthCare (EDQM) will use a new IT application for the management of its activities. The implementation of this tool will entail certain changes in the way...
European network of OMCLs News 22 September 2021 Strasbourg, France
The 26th Annual Meeting of the European Network of Official Medicines Control Laboratories (OMCLs) took place from 6 to 10 September 2021 and was held virtually due to the ongoing pandemic situation. The meeting, organised by the European Directorate for the Quality of Medicines...
Transplantation / Publications / Transplant Newsletter News 21 September 2021 Strasbourg, France
The 2021 edition of the Newsletter Transplant has just been published. It summarises comprehensive information and data for 2020 from 82 countries worldwide on donation and transplantation activities, management of waiting lists, organ donation refusals and authorised centres for...

More news

CEP holders are requested to consult the list of substances for which draft revised monographs of the European Pharmacopoeia (Ph. Eur.) have been published in Pharmeuropa 33.3.
Supplement 10.6 of the European Pharmacopoeia (Ph. Eur) is now available. CEP holders are invited to update their applications according to the revised monographs that will be implemented on 1 January 2022, and to follow the...
A new draft monograph, Golimumab concentrated solution (3103), has been published in this quarter’s issue of Pharmeuropa (33.3), the European Pharmacopoeia (Ph. Eur.) online forum for comment.

Agenda

05 October 2021 to 07 October 2021
Strasbourg, France
20 October 2021 to 25 November 2021
online
Nitrosamine contamination
In brief

Since N-nitrosamines, possible carcinogens for humans, were detected in 2018 in a number of active substances, the EDQM has been working with regulatory authorities to ensure that no medicinal products containing nitrosamine contaminants reach the end user. This has involved, among others, reviewing Certificates of suitability (used in marketing authorisation applications), revising European Pharmacopoeia monographs for the active substances concerned and establishing new reference standards to support the implementation of the new Ph. Eur. general chapter on the analysis of N-nitrosamines. The EDQM OMCL Network has also co-ordinated the development of testing procedures that ensure adequate control of impurities and a risk-based sampling and testing programme.

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
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 the 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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Via our web store at store.edqm.eu in order to benefit from free handling charges (on publications only). Alternatively, you can send your order to the EDQM Sales section by:

  • post: EDQM – Council of Europe, 7 allée Kastner, CS 30026, 67081 Strasbourg, France
  • e-mail: orders@edqm.eu

Invoices can be paid by credit card via internet or by bank transfer.

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