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EDQM co-sponsors ICDRA 2018 Conference
European Pharmacopoeia / International harmonisation News 14 August 2018 Strasbourg, France
The EDQM is proud to be co-sponsoring the 18th International Conference of Drug Regulatory Authorities (ICDRA) which will take place in Dublin (Ireland) from 03 to 07 September.
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Office Closure on 15 August
EDQM News 13 August 2018 Strasbourg, France
The EDQM would like to inform you that its office will be closed on Wednesday 15 August 2018 for public holiday
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Certification Monthly Report of Activities: July 2018
Certification of suitability (CEP) / Procedure of certification (general) News 13 August 2018 Strasbourg, France
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.
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Pharmeuropa Volume 30 No 3, July 2018
Users of CEPs are invited to provide comments on draft monographs published in Pharmeuropa 30.3 before 30 September 2018.
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EDQM’s actions to evaluate impact of impurity in active substance...
The EDQM is aware of a quality defect related to an impurity in the active substance valsartan used in medicines to treat high blood pressure marketed in Europe.
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Falsification of medical products: a revised version of Know-X...
This project will favour better interaction between the analytical and enforcement actors involved in the fight against falsified medicines and medical devices.
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Agenda

18 September 2018
Strasbourg, France
Workshop ‘What’s new in the field of excipients in China?’
26 September 2018
Strasbourg, France
FREE Webinar - ‘the newly revised EDQM Guideline on requi...
09 October 2018 to 11 October 2018
Madrid, Spain
CPhI Worldwide 2018

See all events

See Reference standards Catalogue
See Reference standards Catalogue
Ph. Eur. 9th Edition presentation
Ph. Eur. 9th Edition presentation
Reference Standards & publication store
Reference Standards & publication store
Free Publications and Databases
Free Publications and Databases
Certification of Suitability (CEP) News
Certification of Suitability (CEP) News
Have a question? FAQ & HelpDesk
https://www.edqm.eu/en/news/all
The Vision of the EDQM
In brief
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  • 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.
https://www.edqm.eu/en/news/european-pharmacopoeia
The European Pharmacopoeia
In brief
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  • 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 countries (including the EU) and 30 observers (including WHO and TFDA) as of December 2017.
https://www.edqm.eu/en/news/omcl-network
Official Medicines Control Laboratories (OMCL)
In brief
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  • 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.
https://www.edqm.eu/en/news/certification-of-suitability
The Certification of Suitability
In brief
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  • 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.

 

https://www.edqm.eu/en/news/transfusion-and-transplantation
HealthCare Activities
In brief
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  • Blood Transfusion & Organ Transplantation: elaborating ethical, legal and safety standards.
  • Pharmaceutical Care : developing and promoting best practices
  • Anti-counterfeiting activities: supporting the protection of public health.
  • Cosmetics & Packaging Materials: focusing on the safe use of cosmetics and packaging materials for food and medicines.
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https://www.edqm.eu/en/membership-observership
Ph. Eur. Commission: Uzbekistan became the 30th Observer
Focus
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During its March 2018 session, the Ph.Eur. Commission unanimously decided to grant Uzbekistan observer status. This brings to 30 the number of observers, from 6 continents. As observer, Uzbekistan can participate in the scientific work of the Commission and its expert meetings, attend Commission sessions and become involved in other EDQM activities. Observer status also facilitates development of a mutually-beneficial relationship and sharing of expertise on issues pertinent to the quality of medicines and healthcare.

More information on Ph. Eur. Members and observers.

Latest products and services

17 July 2018
4 elemental impurity chemical reference standards (CRS) available in...
13 July 2018
25 New batches of Ph. Eur. Reference Standards released
07 June 2018
New Ph. Eur. Reference Standards released in May 2018
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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
  • email: orders@edqm.eu

Invoices can be paid by credit card via internet or by bank transfer.

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Videos

https://www.edqm.eu/en/../en/presentation-edqm
https://www.edqm.eu/en/../en/9th-edition-european-pharmacopoeia-maintaining-high...
https://www.edqm.eu/en/../en/inside-the-council-of-europe
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