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Major 3Rs achievement for Official Control Authority Batch Release of human vaccines
European network of OMCLs / Human Biologicals (OCABR) / Vaccines News 11 December 2018 Strasbourg, France
In line with the removal of the abnormal toxicity test (ATT) from the European Pharmacopoeia (Supplement 9.6), the 21 product-specific guidelines for Official Control Authority Batch Release (OCABR) of vaccines for human use that contained references to the ATT in the manufacturer’s...
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EDQM welcomes WHO recommendation to discontinue innocuity test in guidelines on vaccines and biologicals
European Pharmacopoeia / Animal testing News 06 December 2018 Strasbourg, France
The EDQM has welcomed the recommendation of the WHO Expert Committee on Biological Standardization (ECBS) to omit the abnormal toxicity test (also called the innocuity test) in all future WHO documents on vaccines and other biological products, and to disregard the inclusion of this...
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Outcome of the 162nd Session of the European Pharmacopoeia Commission
European Pharmacopoeia / Ph. Eur. Commission News 30 November 2018 Strasbourg, France
At its 162nd Session in Strasbourg on 20-21 November 2018, the European Pharmacopoeia (Ph. Eur.) Commission adopted 16 new texts and 128 revised texts. All of the adopted texts help ensure that the Ph. Eur. remains up to date and in line with the latest regulatory developments and...
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Revised EDQM Guidelines concerning the procedure for ‘Certification...
Following introduction of the revised Guideline on requirements for revision/renewal of Certificates of Suitability to the European Pharmacopeia Monographs’ (PA/PH/CEP (04) 2, 7R corr) several EDQM policy documents have been revised...
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EDQM revised guideline on Content of the dossier for chemical purity...
The revised EDQM guideline Content of the dossier for chemical purity and microbiological quality, PA/PH/CEP (04) 1, 6R will enter into force in January 2019.
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Certification Monthly Report of Activities: November 2018
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.
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Agenda

29 January 2019 to 30 January 2019
Strasbourg, France
International Symposium on ‘Plasma Supply Management’
13 March 2019 to 14 March 2019
Strasbourg, France
NEW: JOINT EDQM-USP ‘13th International Symposium on Pha...
18 June 2019 to 20 June 2019
Shanghai, China
NEW: CPhI China & CEP One-to-One Sessions

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

06 November 2018
End of year delivery deadlines for shipment of EDQM Publications...
24 October 2018
Recently released: 2 new Ph. Eur. Reference standards Zoledronic...
27 September 2018
Ph. Eur. Supplement 9.7 available now
See all Products and Services news

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.

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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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