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European Pharmacopoeia / General text/chapter News 12 February 2020 Strasbourg, France
At its 165th session in November 2019, the European Pharmacopoeia Commission adopted a new version of one of its widely used general methods, chapter 2.2.2. Degree of coloration of liquids, which has been extensively revised to include the instrumental method. The revised chapter...
Products and Services News 12 February 2020 Strasbourg, France
Due to the coronavirus situation, the EDQM is experiencing issues in shipping reference standards to China. As the situation changes quickly, the EDQM contacts all concerned users in order to agree on the best possible option.
Certification of suitability (CEP) / Procedure of certification (general) News 12 February 2020 Strasbourg, France
Supplement 10.2 of the Ph. Eur is now available. CEP holders are invited to update their applications according to the revised monographs that will be implemented on the 1st of July 2020, and to follow the instructions given in the document.

More news

The Ministry of Health and Family Welfare of India has lifted the ban on Oxytocin reference standards imported exclusively for the purpose of test and analysis. The EDQM is therefore in a position to ship Oxytocin CRS (catalogue...
The European Pharmacopoeia (Ph. Eur.) has launched a public consultation on its new general chapter 2.8.26 on contaminant pyrrolizidine alkaloids. Users and concerned parties can submit their comments in Pharmeuropa 32.1 until 31...
The EDQM is pleased to announce that the European Paediatric Formulary is now available free of charge on a dedicated online platform. This is a major achievement for the PaedForm Working Party and all the stakeholders involved, since...

Agenda

01 April 2020 to 02 April 2020
Strasbourg, France
21 April 2020 to 23 April 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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Meet the World Pharmacopoeias Symposium
Focus

This one-day symposium will include background information on the International Meeting of World Pharmacopoeias and will explain the scope and content of the Good Pharmacopoeial Practices.

The speakers’ panel will bring together representatives of pharmacopoeias and stakeholders from around the world to present and discuss opportunities and challenges surrounding international co-operation and the harmonisation of pharmacopoeial texts.

This symposium is of interest to professionals from the pharmaceutical industry and regulatory agencies.

If you cannot make it to Strasbourg, you can register to attend this symposium remotely, by connecting to the internet link provided (webinar system).

More information available on the event webpage Meet the World Pharmacopoeias Symposium.

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  • e-mail: orders@edqm.eu

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