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European network of OMCLs News 21 September 2018 Strasbourg, France
Since early July 2018, OMCLs have been involved in investigations and actions to address the issues related to the detection of N-nitrosodimethylamine (NDMA) in valsartan. The Network has meanwhile developed methods for the specific testing of nitrosamines in sartans on the basis...
Certification of suitability (CEP) / Procedure of certification (general) News 21 September 2018 Strasbourg, France
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.
European Pharmacopoeia / General News 18 September 2018 Strasbourg, France
The EDQM has provided a platform for European and international medicine manufacturers to discuss new regulatory approaches in China on pharmaceutical excipients selection and quality control. During a workshop on 18 September in Strasbourg, the Chinese Pharmacopoeia (ChP) delivered...

More news

The revised EDQM ‘Guideline on requirements for revision/renewal of Certificates of Suitability to the European Pharmacopoeia Monographs’ (PA/PH/CEP (04) 2 7R) will enter into force in January 2019.
A symposium on ‘Plasma Supply Management’ will take place on 29-30 January 2019 in Strasbourg. This symposium will discuss the facts and scientific evidence surrounding the collection of plasma for fractionation and the elaboration of...
Users of CEPs are invited to provide comments on draft monographs published in Pharmeuropa 30.3 before 30 September 2018.

Agenda

09 October 2018 to 11 October 2018
Madrid, Spain
09 October 2018 to 10 October 2018
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 countries (including the EU) and 30 observers (including WHO and TFDA) as of December 2017.
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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Ph. Eur. Commission: Uzbekistan became the 30th Observer
Focus

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.

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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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