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Certification of suitability (CEP) / Procedure of certification (general) | News | 09 November 2017 | Strasbourg, France
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.
Products and Services | News | 07 November 2017 | Strasbourg, France
The EDQM will be closed from December 22nd afternoon until January 2nd. Please find below the ordering deadlines to receive your order in 2017.
Transplantation / Organ trafficking | News | 07 November 2017 | Strasbourg, France
The Council of Europe Convention against Trafficking in Human Organs will come into force after ratification by Malta on 07 November 2017. This is the fifth ratification, following those of Albania, Norway, the Republic of Moldova and the Czech Republic, and it triggers the Convention’s entry into force. These five ratifying member states will be bound by the Convention as of 01 March 2018.
Pharmaceutical care / Indicators for the quality | News | 03 November 2017 | Strasbourg, France
The EDQM has just published the final report of its Pharmaceutical Care Quality Indicators Project.
Consumer Health protection / Cosmetics / Tattoo | News | 02 November 2017 | Strasbourg, France
The European Directorate for the Quality of Medicines & HealthCare (EDQM) today issued a compendium of the scientific information currently available on the potential toxicity of intradermal inks.
European Pharmacopoeia / Pharmacopoeial discussion group (PDG) | News | 26 October 2017 | Strasbourg, France
The meeting of the Pharmacopoeial Discussion Group (PDG) [European Pharmacopoeia (Ph.Eur.), Japanese Pharmacopoeia (JP), and the United States Pharmacopoeia (USP)] was hosted by USP in Rockville, Maryland, U.S.A., September 12-13 2017.
Transfusion / Blood Quality Management system (B-QM) | News | 26 October 2017 | Strasbourg, France
The EDQM has cast a light on the importance of supporting Blood Establishments (BEs) in implementing Quality Management (QM) elements such as risk management, change control and validation/qualification, as well as of delineating their practical implementation.
European Pharmacopoeia / Alternative method | News | 20 October 2017 | Strasbourg, France
Microbiological control symposium: consensus on readiness of new methods emerges A symposium on microbiology in the pharmaceutical sector was the opportunity for the EDQM to gather feedback from users of the European Pharmacopoeia on alternative testing methods for microbiological control and sterilisation processes.
Certification of suitability (CEP) | News | 12 October 2017 | Strasbourg, France
Users of CEPs are invited to provide comments on draft monographs published in Pharmeuropa 29.4 before 31st December 2017.
Certification of suitability (CEP) | News | 12 October 2017 | Strasbourg, France
Supplement 9.4 of the Ph. Eur is now available. CEP holders are invited to update their applications according to the revised monographs that will be implemented on the 1st of April 2018, and to follow the instructions given in the document
Certification of suitability (CEP) | News | 11 October 2017 | Strasbourg, France
The European Directorate for the Quality of Medicines & HealthCare (EDQM) and ANVISA, the Health Surveillance Agency of Brazil, have signed a Memorandum of Understanding which lays the foundation for ANVISA to consider the use of Certificates of Suitability to the monographs of the European Pharmacopoeia (CEPs) for their evaluation of marketing authorisation applications (MAAs) for medicinal...
Certification of suitability (CEP) / CEP new application | News | 10 October 2017 | Strasbourg, France
As of 1 January 2018: eCTD mandatory for new CEP applications and NeeS or eCTD for revision or renewal applications
Products and Services | News | 02 October 2017 | Strasbourg, France
Pharmeuropa contains draft pharmacopoeial texts for which the European Pharmacopoeia Commission is seeking comment.
Transplantation / Organ trafficking | News | 28 September 2017 | Strasbourg, France
With the Czech Republic becoming its 4th ratifying party on 21 September, the Convention against Trafficking in Human Organs is getting closer to coming into force. The country is one of the initial signatory Member States to the Convention, when this was first opened for signature in 2015; its ratification was preceded by those of Albania, Norway and the Republic of Moldova.
Certification of suitability (CEP) / Procedure of certification (general) | News | 27 September 2017 | Prague, Czech Republic
The EDQM held a 2-day conference in Prague to exchange with the worldwide pharmaceutical sector and to keep authorities and manufacturers alike informed of recent developments and of the future of its Certification of suitability to the monographs of the European Pharmacopoeia in the global regulatory environment.