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Paediatric Formulary News 27 March 2020 Strasbourg, France
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...
European Pharmacopoeia / Animal testing News 24 March 2020 Strasbourg, France
At its 165th session (November 2019), the European Pharmacopoeia (Ph. Eur.) Commission adopted 16 revised monographs on tetanus vaccines, following a re-assessment of toxicity testing requirements. The revisions include the suppression of three tests and the harmonisation, as far as...
European Pharmacopoeia / Announcements News 24 March 2020 Strasbourg, France
Are you ready to comply with the new European Pharmacopoeia (Ph. Eur.) revised text on extraneous agent testing in immunological veterinary medicinal products (IVMPs)? The approach to extraneous agent testing in IVMPs has recently been updated and manufacturers of these products are...

More news

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...
The EDQM Laboratory successfully obtained accreditation for the 2017 version of the ISO 17025 standard from the Belgian accreditation organisation BELAC in February 2020, confirming the validity of the results generated for its Ph....
The EDQM organised the one-day “Meet the World Pharmacopoeias” Symposium on 20 February 2020 at the EDQM premises in Strasbourg, after the 11th International Meeting of World Pharmacopoeias (IMWP), which was also hosted at its...

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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Keeping up with Reality and Quality: A Challenge for...
Focus
The year 2020 will mark 10 years of successful collaboration between the European Union and the EDQM in the field of blood, 10 years in which scientific, regulatory, societal, economic and other transversal domains have evolved rapidly. European Blood Establishments (BEs) are required to continuously adapt their Quality Systems (QSs) in light of new developments in these domains, while pursuing the public health objective of ensuring continuity of blood supplies. 
From 29 September to 1st October 2020, the EDQM and the EU will celebrate 10 years of successful collaboration and, building on the horizon scanning approach, will hold a conference to address the following key topics: the new General Data Protection Regulation (GDPR) and data integrity; demographic changes among blood healthcare professionals; the globalisation of the market supply of medical devices, material and equipment; the new Medical Device (MD) and In Vitro Medical Device (IVD) Regulations; and contingency planning and business continuity. 

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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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