Council for europe portal
Language : en Search
Choose language
European Pharmacopoeia / International harmonisation News 21 February 2020 Strasbourg, France
At the 11th International Meeting of the World Pharmacopoeias (IMWP) co-hosted by the WHO and the EDQM in Strasbourg (France), national and regional pharmacopoeias brought forward initiatives to strengthen their co-operation as a way to improve public health outcomes for patients.
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.

More news

At its 165th session in November 2019, the European Pharmacopoeia Commission adopted two general chapters related to testing for particulate contamination in pharmaceutical preparations.
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...

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.

 

1
2
3
4
5
Keeping up with Reality and Quality: A Challenge for...
Focus
Celebrating the 10th anniversary of EU/EDQM co-operation in the field of blood

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. While many of these developments may be beneficial, BEs often lack the necessary resources or capacity to implement the changes they imply and this can also put the achievement of their objectives at risk. 

BEs have faced, and will face in the years to come, a number of issues arising from recent developments, such as new provisions on data protection, new regulations on medical devices, the globalisation of the market supply of medical devices, material and equipment, as well as demographic changes. These issues have been observed during audits carried out in European BEs, under the aegis of the EDQM's B-QM Programme, and they have been addressed on several occasions as part of the ongoing evaluation of EU blood legislation. It is also anticipated that these issues will affect the QSs of BEs. 

The EDQM, in collaboration with the European Commission, is organising a conference to provide stakeholders with a forum to discuss these challenges. It is essential that stakeholders work together in the early stages to ensure that decision makers are informed about opportunities and threats, and that the measures are taken in order to mitigate risks and ensure the most beneficial outcomes. 

From 21 to 23 April 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. 

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