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European Pharmacopoeia / Ph. Eur. Commission News 15 January 2021 Strasbourg, France
At its 168th session, the Ph. Eur. Commission adopted Fritillariae thunbergii bulbus (2588), the first monograph to describe a test for minimum content of two markers (peimine and peiminine) by high-performance thin layer chromatography (HPTLC).
News 13 January 2021 Strasbourg, France
The European Directorate for the Quality of Medicines & HealthCare’s (EDQM) ISO 9001:2015 certificate has been maintained following the second surveillance audit of its quality management system on 7 and 8 December 2020 by the official French standardisation body Association...
Certification of suitability (CEP) / Procedure of certification (general) News 12 January 2021 Strasbourg, France
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.

More news

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just released Issue 3 of Pharmeuropa PaedForm, in which the draft text for Phosphate 60 mg/mL Oral Solution is published for public consultation prior...
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has released an updated set of pharmacopoeial quality standards for vaccines.
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published three new Official Control Authority Batch Release (OCABR) guidelines outlining the tests to be performed by Official Medicines Control...

Agenda

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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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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