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Ph. Eur. endorses semi-quantitative HPTLC testing for traditional Chinese medicines
European Pharmacopoeia / Ph. Eur. Commission News 17 April 2019 Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) Commission has decided to accept semi-quantitative High-Performance Thin-Layer Chromatography (HPTLC) tests as an alternative quality control which could be used instead of liquid chromatography (LC) assays in monographs on Traditional Chinese...
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Certification Monthly Report of Activities: March 2019
Certification of suitability (CEP) / Procedure of certification (general) News 10 April 2019 Strasbourg, France
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.
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Pharmeuropa Volume 31 No 2, April 2019
Certification of suitability (CEP) / Procedure of certification (general) News 10 April 2019 Strasbourg, France
Users of CEPs are invited to provide comments on draft monographs published in Pharmeuropa 31.2 before 30 June 2019.
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First OMCL Network test method for the determination of NMBA in...
Since the start of the sartan crisis in summer 2018, OMCLs of the European Network have elaborated a number of test methods to qualify and quantify nitrosamines in Active Pharmaceutical Ingredients (APIs) and drug products of the...
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Fast track revision of monograph Dipotassium clorazepate monohydrate...
It has been brought to our attention that the conversion factor of 13.63 prescribed in the assay is inappropriate and leads to an overestimation of the content. Therefore, it has to be replaced by a factor of 13.03.
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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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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/news/call-experts-join-ph-eur-network
Call for experts: Join the Ph. Eur. Network!
Focus
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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 control laboratories, licensing authorities and inspectorates), the private sector (pharmaceutical or chemical industries), academia, research organisations and other experts are encouraged to apply. This is an ideal opportunity to take part in the work of the Ph. Eur., to network with professionals with various backgrounds and from all over Europe and beyond, and to help shape Ph. Eur. texts, internationally-recognised quality standards for medicines.

More information on Ph. Eur. Members and observers.

Latest products and services

09 April 2019
4 new Ph. Eur. Reference Standards (RS) and 21 replacement batches...
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...
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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
  • 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...
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