AA

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?

25 March 2015

151st session of the European Pharmacopeoia Commission

The European Pharmacopoeia Commission adopted 24 new texts (20 monographs...

Read more

19 March 2015
Walk against Organ Trafficking’: EDQM’s steering committee on Organ Transplantation takes the lead

The European Committee in charge...

Read more

16 March 2015

27th DIA EuroMeeting set to be landmark event

13-15 April 2015 in Paris, France

The DIA Annual EuroMeeting brings together...

Read more

Focus

Organ Donation & Human Rights

By the end of 2013, more than 70 000 patients were waiting for an organ transplant in the European Union (EU), as shown in the latest edition of Newsletter Transplant.

Recently, Spain ratified the Additional Protocol to the Convention on Human Rights and Biomedicine concerning Transplantation of Organs and Tissues of Human Origin (ETS No. 186). The Protocol considers that appropriate action should be taken to increase organ and tissue donation, in particular by informing the public of its importance and by promoting European co-operation in this field.

 

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.

 

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 4 countries.

Moldova is the latest country to have ratified the Convention (14/08/2014).

 

> More on the Medicrime Convention

Organ Donation & Human Rights

By the end of 2013, more than 70 000 patients were waiting for an organ transplant in the European Union (EU), as shown in the latest edition of Newsletter Transplant.

Recently, Spain ratified the Additional Protocol to the Convention on Human Rights and Biomedicine concerning Transplantation of Organs and Tissues of Human Origin (ETS No. 186). The Protocol considers that appropriate action should be taken to increase organ and tissue donation, in particular by informing the public of its importance and by promoting European co-operation in this field.

 

14 June 2015

World Blood Donor Day

24-26 June 2015

CPhI China

Shanghai, China

27 June - 1 July 2015
25th Regional Congress of the ISBT

London, United Kingdom

Products & Services

Proficiency Testing Studies (PTS)

Participate in a study

The EDQM designs and organises a number of PTS every year in the areas of physico-chemical, biologicals, blood and cosmetics. The 2015 PTS schedules are now available and registrations are open. If your organisation would like to participate in a study, please completed the relevant registration form and submit it to the EDQM.

 

Pharmeuropa Online

Issue 27.1 now complete

Deadline for comments: 31 March 2015

 

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 December 2014 session
> More on Pharmeuropa Online

Launch of the new Standard Terms database

A new version of the Standard Terms database has been launched online, with access available free of charge upon registration. The database has undergone a major revision and reorganisation, allowing greater flexibility in searching, viewing and editing terms.

Anyone wishing to access the database can do so free of charge once they have requested a user account via the EDQM Publications registration website

Contents of Supplement 8.5

Discover now the list of new and revised texts that will be implemented on 1st July 2015

 

Supplement 8.5 includes 6 new and 47 revised texts, see its list of content and the 8th edition’s cumulative index.

This new supplement will be released in January 2015.

 

EDQM Reference Standards

List of 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

Guide to the preparation, use and quality assurance of blood components – 17th Edition

Now available in Russian

The Guide to the preparation, use and quality assurance of blood components – 17th Edition is now available in Russian thanks to the Autonomous Nonprofit Organization «Central Scientific-Research Institute of Transfusion Medicine and Medical Technologies».

Proficiency Testing Studies (PTS)

Participate in a study

The EDQM designs and organises a number of PTS every year in the areas of physico-chemical, biologicals, blood and cosmetics. The 2015 PTS schedules are now available and registrations are open. If your organisation would like to participate in a study, please completed the relevant registration form and submit it to the EDQM.

 

Disclaimer - Created by 2exVia with MasterEdit®