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European Pharmacopoeia News 07 April 2020 Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) seeks feedback on its new general chapter on the analysis of N-nitrosamine impurities in active substances (2.4.36).
Certification of suitability (CEP) / Procedure of certification (general) Notification 07 April 2020 Strasbourg, France
Users of CEPs are invited to provide comments on draft monographs published in Pharmeuropa 32.2 before 30 June 2020. More information in document PA/PH/CEP (20) 17.
EDQM / All activities News 06 April 2020 Strasbourg, France
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...

More news

The European Paediatric Formulary (PaedF) Working Party, in this exceptional situation, wishes to serve pharmacists by compiling existing knowledge on paediatric formulations for active substances under investigation as well as known...
In January 2017, the EDQM published an update on the European Pharmacopoeia (Ph. Eur.) policy on elemental impurities in which the special case of excipients of natural origin was highlighted. At the time, and based on feedback...
The EDQM recognises that due to the impact of the global outbreak of COVID-19, many CEP holders are encountering significant challenges in completing the work within the timelines previously announced in the EDQM request to CEP...

Agenda

07 July 2020 to 08 July 2020
Strasbourg, France
29 September 2020 to 01 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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Paediatric formulations that may be useful in the treatment...
Focus

The European Paediatric Formulary (PaedF) Working Party, in this exceptional situation, wishes to serve pharmacists by compiling existing knowledge on paediatric formulations for active substances under investigation as well as known authorised medicinal products. Information on paediatric formulations of active substances used in clinical trials but also experimentally in clinical practice throughout the world will therefore be gathered and published in tables on the EDQM website, by the PaedF Working Party. These tables will be continuously updated and will be living documents.

The complete information and tables for Chloroquine, Hydroxychloroquine and Lopinavir/Ritonavir can be found here.

 

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