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News 01 March 2021 Strasbourg, France
The European Pharmacopoeia Commission has revised via a rapid implementation procedure the five “sartan” monographs (Valsartan, Losartan potassium, Candesartan cilexetil, Olmesartan medoximil and Irbesartan); they will enter into force on 1 April 2021 to align them with the CHMP...
News 24 February 2021 Strasbourg, France
The European Committee on Blood Transfusion (CD-P-TS) has approved the publication of the 2016 edition of “The collection, testing and use of blood and blood components in Europe”. In total, 28 Council of Europe member states, representing some 430 million inhabitants, reported...
News 23 February 2021 Strasbourg, France
The five monographs on sartans with a tetrazole ring, namely Valsartan (2423), Losartan potassium (2232), Irbesartan (2465), Candesartan cilexetil (2573) and Olmesartan medoxomil (2600) have been revised to align them with the latest regulatory recommendations issued by the CHMP that...

More news

This webinar is intended to support users and stakeholders in the swift implementation of the new general chapter 2.6.32. Test for bacterial endotoxins using recombinant factor C by answering the following questions: What...
The European Pharmacopeia (Ph. Eur.) regularly updates its dosage form monographs and related general chapters to ensure that they continue to reflect current practices and scientific progress. Pharmeuropa 33.1, this quarter’s issue,...
The EDQM announces the availability of 5 new European Pharmacopoeia (Ph. Eur.) reference standards and 17 replacement batches for Ph. Eur. reference standards in January 2021.

Agenda

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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