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The Vision of the EDQM

  • 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.

  • Develops also guidance and standards in the areas of blood transfusion, organ transplantation and consumer health issues.

> What’s new at the EDQM?

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.

  • 38 signatory parties (including the EU) and 27 observers (including WHO) as of 09 April 2014.

 > More about the European Pharmacopoeia

Official Medicines Control Laboratories (OMCL) in Brief

  • A network of official laboratories appointed by the national authorities.

  • 80 laboratories pool human and technical resources to implement testing programmes.

  • 30 European countries participate in the various activities and programmes.

> More about OMCLs

The Certification of Suitability (CEP) in Brief

  • Established in 1994.

  • Over 3500 certificates covering 850 substances have been granted  in more than 50 countries.

  • Assessment is jointly performed by assessors from the national competent authorities and EDQM assessors

  • Organises an inspection programme to check compliance with both GMP and the CEP with a network of national inspectors.

> More about CEPs

Healthcare Activities in Brief

  • Blood Transfusion & Organ Transplantation: elaborating ethical, legal and safety standards.

  • Pharmaceutical Care : developing and promoting best practices

  • Anti-counterfeiting activities: supporting public health protection.

  • Cosmetics & Packaging Materials: focusing on the safe use of cosmetics and packaging materials for food and medicines.

> More about Healthcare

The Vision of the EDQM

  • 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.

  • Develops also guidance and standards in the areas of blood transfusion, organ transplantation and consumer health issues.

> What’s new at the EDQM?

09 April 2014

Certification Monthly Report of Activities

The last monthly activity report for the Certification of Substances Division (DCEP) is...

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04 April 2014

148th Session of the European Pharmacopoeia Commission

During its 148th session, the European Pharmacopoeia Commission adopted...

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27 March 2014
Certification - Clarification of Policy of Two rounds of Evaluation

The Certification Division has published a document on its...

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Focus

EDQM 50th Anniversary

50 years of leadership in the quality of medicines

50th anniversary EDQMFor 50 years now, the EDQM has shown leadership in protecting public health by enabling the development, supporting the implementation and monitoring the application of quality standards for safe medicines and their safe use.

Join the EDQM to celebrate the 50th anniversary of the Convention on the elaboration if a European Pharmacopeia on 6-8 October 2014!

> Discover the programme and list of workshops

European Pharmacopoeia

Member & Observers

Map of member and observer countries 2014During its 148th Session, the PhEur Commission unanimously decided to grant Azerbaijan observer status. This brings to 27 the number of observers, from 6 continents. As an observer, Azerbaijan can participate in the scientific work of the Commission and its expert meetings, attend Commission sessions and become involved in the other EDQM activities. Observer status also facilitates development of a mutually-beneficial relationship and sharing of expertise on issues pertinent to the pharmaceutical and healthcare sector.

 

Kidney Donation

New resolution to optimise donation programmes

Organ Donation heart logo

Even though many countries with established transplant programmes have improved their deceased donation rates, none can cover the true need for kidneys from this source. A new Resolution CM/Res(2013)56 “on the development and optimisation of live kidney donation programmes” recommends that member states develop and optimise programmes for kidney donation from live donors based on recognised ethical and professional standards as a better way to pursue self-sufficiency in transplantation.

 

>> More on Conventions, recommendations and resolutions

Transplantation activities

Committee of Ministers adopts new resolution

The Committee of Ministers has adopted a new Resolution CM/Res(2013)55 on “establishing procedures for the collection and dissemination of data on transplantation activities outside a domestic transplantation system”. This Resolution recommends that member states designate a contact person to regularly collect data on patients going abroad for transplantation of an organ retrieved as a result of illicit transplantation procedures performed outside the framework of a domestic transplantation system, and that they develop and implement an appropriate tool for such data collection.

>> More on EDQM Projects


The Medicrime Convention


Medicrime posterThe Medicrime Convention, drawn up by the Council of Europe, is the first international treaty against counterfeit medical products and similar crimes involving threats to public health.

The Convention has been signed by 20 countries, member and non-member states of the Council, and ratified by 3 countries.

Hungary is the latest country to have ratified the Convention (09/01/14).

 

> More on the Medicrime Convention

EDQM 50th Anniversary

50 years of leadership in the quality of medicines

50th anniversary EDQMFor 50 years now, the EDQM has shown leadership in protecting public health by enabling the development, supporting the implementation and monitoring the application of quality standards for safe medicines and their safe use.

Join the EDQM to celebrate the 50th anniversary of the Convention on the elaboration if a European Pharmacopeia on 6-8 October 2014!

> Discover the programme and list of workshops

30 May - 5 June 2014

33rd International Congress of the ISBT

Seoul, South Korea

3-4 June 2014

Veterinary Batch Release Network Workshop

Strasbourg, France

14 June 2014

World Blood Donor Day

Products & Services

Pharmeuropa Online

Issue 26.2 now complete

Deadline for comments: 30 June 2014

NEW: List of texts adopted at the March 2014 session of the PhEur Commission now available

 

Pharmeuropa contains draft pharmacopoeial texts for which the European Pharmacopoeia Commission is seeking comment. If you would like to receive e-mail alerts when an issue is complete, please register for Pharmeuropa online.

 

> More about the March 2014 session
> More on Pharmeuropa Online

 

Safe Cosmetics for Young Children available in Spanish

Safe Cosmetics for Young Children (1st Edition 2012) is now available online for free in its Spanish version thanks to the Agencia espanola de medicamentos y productos sanitarios (AEMPS). The Guide provides guidance and support for manufacturers and safety assessors thanks to a set of safety criteria for cosmetic formulations that should be taken into account when placing a product on the market. This guide particularly emphasises the importance of evaluating the safety of cosmetic products for infants.

New publication

Metals and alloys used in food contact materials and articles

1st Edition 2013
Metals and Alloys 1st EditionThis new Technical guide is intended to ensure the safety and suitable quality of food contact materials and articles made from metals and alloys. It provides useful information and support to professionals in the food contact materials industry, national authorities as well as national policy makers.

> Visit the EDQM Store

> Packaging Guides

8th Edition Packages

8th edition european pharmacopoeia


The EDQM proposes three different packages for customers that wish to purchase several formats at the same time. The electronic versions (USB Key & Online) are completely cumulative and have some unique features such as fully searchable; hyperlinks in the text of a monograph give access to information on general methods as well as links to the EDQM’s Knowledge and Reference Standards databases.


> Check out the different packages on EDQM Store 

EDQM Reference Standards

New batches and products available daily


The EDQM supplies over 2400 reference standards. Information on the standards is freely available via its online database which gets updated daily. This database also provides a link to the entire catalogue and a list of the newly adopted batches and new products.


 > Find out more about EDQM Reference standards

Pharmeuropa Online

Issue 26.2 now complete

Deadline for comments: 30 June 2014

NEW: List of texts adopted at the March 2014 session of the PhEur Commission now available

 

Pharmeuropa contains draft pharmacopoeial texts for which the European Pharmacopoeia Commission is seeking comment. If you would like to receive e-mail alerts when an issue is complete, please register for Pharmeuropa online.

 

> More about the March 2014 session
> More on Pharmeuropa Online

 

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