Council for europe portal
Language : en Search
Choose language
Certification of suitability (CEP) / Procedure of certification (general) News 22 October 2020 Strasbourg, France
The EDQM is launching a project to design the CEP of the future. The consultation will remain open until 31 December 2020 in the form of an online survey.
Patient & Consumer Protection / Food contact material News 19 October 2020 Strasbourg, France
The Committee of Ministers of the Council of Europe has adopted a new resolution on the safety and quality of materials and articles for contact with food. This instrument is expected to improve the protection of consumers from contaminants (metals, antioxidants, stabilisers,...
Paediatric Formulary News 16 October 2020 Strasbourg, France
The European Paediatric Formulary (PaedF) Working Party has published a table compiling existing information on dexamethasone formulations that may be useful in the treatment of paediatric patients with COVID-19.

More news

The Pharmacopoeial Discussion Group (PDG), which brings together the European Pharmacopoeia, the Japanese Pharmacopoeia and the United States Pharmacopeia, held its annual autumn meeting via videoconference on 22-23 September 2020,...
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.
The Committee of Ministers of the Council of Europe has adopted two new recommendations, calling on member states to ensure that quality and safety standards for the donation and transplantation or human application of organs, tissues...

Agenda

27 October 2020 to 29 October 2020
Strasbourg, France
12 December 2020 to 16 December 2020
Barcelona, Spain
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.

 

1
2
3
4
5
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.

 

Latest products and services

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.

@Edqm_news on Twitter

Videos