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Transfusion / Donations Campaigns & World Blood Donor Day (WBDD) News 14 June 2021 Strasbourg, France
At every moment, someone, somewhere, needs blood. Blood components – plasma, red cells and platelets – are routinely used to save patients’ lives during surgery, after an accident or during acute illnesses, such as cancer or haemophilia. Regular blood donations are needed to give...
European Pharmacopoeia / Biological standardisation programme (BSP) News 11 June 2021 Strasbourg, France
An article on the successful outcome of a recent study of the Biological Standardisation Programme (BSP) of the European Directorate for the Quality of Medicines & HealthCare (EDQM) has been published in Pharmeuropa Bio & Scientific Notes, the EDQM’s free online journal.
Certification of suitability (CEP) / Procedure of certification (general) News 08 June 2021 Strasbourg, France
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.

More news

The European Pharmacopoeia (Ph. Eur.) is seeking stakeholder feedback on the new proposed draft chapter on Cell-based assay for potency determination of TNF-alpha antagonists (2.7.26) published in this quarter’s issue of Pharmeuropa (...
A new, revised version of general chapter 2.9.19. Particulate contamination: sub-visible particles has been published in Pharmeuropa 33.2.
At its 169th session (March 2021), the European Pharmacopoeia (Ph. Eur.) Commission adopted a revised version of chapter 1. General Notices.

Agenda

28 June 2021 to 09 July 2021
Strasbourg, France
05 October 2021 to 07 October 2021
Strasbourg, France
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.

 

 

How to order

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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