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European Pharmacopoeia / Monograph News 16 January 2020 Strasbourg, France
The European Pharmacopoeia Commission adopted a new monograph, on Rosuvastatin tablets (3008), at its 163rd session in March 2019. The monograph was published in Supplement 10.1 of the European Pharmacopoeia (Ph. Eur.), available since October 2019, and will become effective on 1...
European Pharmacopoeia / Monograph News 16 January 2020 Strasbourg, France
With a view to improving the correspondence between liquid chromatography column brand names (provided in the Knowledge Database) and the reagents used to describe the stationary phases for these columns, an overall review of all the monographs concerned has been launched. The names...
European Pharmacopoeia / General text/chapter News 15 January 2020 Strasbourg, France
The EDQM would like to inform you that a new version of the Pharmeuropa website will go live on 23 January 2020. This website will include new features, such as single sign-on for users with access to the European Pharmacopoeia 10th Edition online.

More news

The European Pharmacopoeia (Ph. Eur.) has launched a public consultation on its new general chapter 2.8.26 on contaminant pyrrolizidine alkaloids. Users and concerned parties can submit their comments in Pharmeuropa 32.1 until 31...
The EDQM is pleased to announce that the European Paediatric Formulary is now available free of charge on a dedicated online platform. This is a major achievement for the PaedForm Working Party and all the stakeholders involved, since...
The Ph. Eur. Commission proposes to revise the general monograph on Substances for pharmaceutical use (2034). This proposal has been made further to the European Commission referral C(2019)2698 of 2 April 2019 and the review initiated...

Agenda

04 February 2020 to 05 February 2020
Strasbourg, France
01 April 2020 to 02 April 2020
Strasbourg, France
The Vision of the EDQM
In brief
  • 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.
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.
  • 39 signatory parties (including the EU) and 30 observers (including WHO and TFDA) as of March 2018.
Official Medicines Control Laboratories (OMCL)
In brief
  • 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.
The Certification of Suitability
In brief

 

  • 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.

 

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 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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Meet the World Pharmacopoeias Symposium 20 February 2020
Focus

This one-day symposium will include background information on the International Meeting of World Pharmacopoeias and will explain the scope and content of the Good Pharmacopoeial Practices.

The speakers’ panel will bring together representatives of pharmacopoeias and stakeholders from around the world to present and discuss opportunities and challenges surrounding international co-operation and the harmonisation of pharmacopoeial texts.

This symposium is of interest to professionals from the pharmaceutical industry and regulatory agencies.

If you cannot make it to Strasbourg, you can register to attend this symposium remotely, by connecting to the internet link provided (webinar system).

More information available on the event webpage Meet the World Pharmacopoeias Symposium.

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  • 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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