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Certification Monthly Report of Activities: February 2019
Certification of suitability (CEP) / Procedure of certification (general) News 11 March 2019 Strasbourg, France
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.
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FOLLOW-UP –– Issue with revision of general chapter on Arsenic (2.4.2) in Ph. Eur.
European Pharmacopoeia / General text/chapter News 08 March 2019 Strasbourg, France
The revised limit test for arsenic (Method A, 2.4.2) was published in Supplement 9.4 of the European Pharmacopoeia and entered into force on 1 April 2018. Upon implementation, the EDQM was made aware of a problem with the suitability test (UV-visible absorbance) of the newly...
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3 new Ph. Eur. Reference Standards (RS) and 24 replacement batches released in February 2019
Products and Services News 07 March 2019 Strasbourg, France
The EDQM announces the availability of 3 New Ph. Eur. Reference Standards and 24 Replacement batches for Ph. Eur. Reference Standards.
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The chapter on water: micro determination (2.5.32.) has been revised...
The chapter on water: micro determination (2.5.32.) has been revised in the Ph. Eur. Supplement 9.8. The revised part is reproduced here after: The instrument qualification is carried out according to established quality system...
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Call for experts: Join the Ph. Eur. Network!
The EDQM is renewing its call for expressions of interest to join the European Pharmacopoeia (Ph. Eur.) as an independent scientific expert. Professionals from national authorities (e.g. pharmacopoeial authorities, official medicines...
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Elemental impurities reference standards: leaflets now include...
The EDQM has updated the leaflets of its reference standards for elemental impurities (lead solution CRS, cadmium solution CRS, mercury solution CRS and arsenic solution CRS) with further information to facilitate their use and make...
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Agenda

18 June 2019 to 20 June 2019
Shanghai, China
CPhI China & CEP One-to-One Sessions
19 June 2019 to 20 June 2019
Strasbourg, France
International Conference on the ‘EDQM & European Pharmaco...
22 June 2019 to 26 June 2019
Basel, Switzerland
29th Regional Congress of the ISBT

See all events

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 parties (including the EU) and 30 observers (including WHO and TFDA) as of March 2018.
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

07 March 2019
3 new Ph. Eur. Reference Standards (RS) and 24 replacement batches...
07 February 2019
29 new Ph. Eur. Reference Substances (RS) and 18 replacement batches...
24 January 2019
Ph.Eur. Supplement 9.8 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.

@Edqm_news on Twitter

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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