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European Pharmacopoeia / Public enquiry News 17 January 2019 Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) Commission has launched a public consultation on how the current situation with dissolution testing in Ph. Eur. Finished Products Monographs (FPMs) could be improved.
European Pharmacopoeia / Monograph News 15 January 2019 Strasbourg, France
The EDQM wishes to inform stakeholders that the monograph for Octreotide (2414) will be published in the 10th Edition of the European Pharmacopoeia and will become effective on 1 January 2020.
European Pharmacopoeia / General News 14 January 2019 Strasbourg, France
Monographs and general texts on radiopharmaceutical preparations are elaborated by experts in the field. In order to guide experts on the information to be included in European Pharmacopoeia (Ph. Eur.) monographs, and also to harmonise the style of the different monographs, a Guide...

More news

Following new information received recently by EDQM about the presence of nitrosamine impurities in drug substances covered by certificates of suitability (CEPs), the EDQM has taken immediate actions on CEPs until appropriate...
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...
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.

Agenda

29 January 2019 to 30 January 2019
Strasbourg, France
13 March 2019 to 14 March 2019
Strasbourg, France
18 June 2019 to 20 June 2019
Shanghai, China
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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  • 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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