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European Pharmacopoeia / International harmonisation | News | 14 August 2018 | Strasbourg, France
The EDQM is proud to be co-sponsoring the 18th International Conference of Drug Regulatory Authorities (ICDRA) which will take place in Dublin (Ireland) from 03 to 07 September.
EDQM | News | 13 August 2018 | Strasbourg, France
The EDQM would like to inform you that its office will be closed on Wednesday 15 August 2018 for public holiday
Certification of suitability (CEP) / Procedure of certification (general) | News | 13 August 2018 | Strasbourg, France
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.
Certification of suitability (CEP) / Procedure of certification (general) | News | 08 August 2018 | Strasbourg, France
Users of CEPs are invited to provide comments on draft monographs published in Pharmeuropa 30.3 before 30 September 2018.
Certification of suitability (CEP) / API | News | 27 July 2018 | Strasbourg, France
The EDQM is aware of a quality defect related to an impurity in the active substance valsartan used in medicines to treat high blood pressure marketed in Europe.
Certification of suitability (CEP) / Procedure of certification (general) | News | 20 July 2018 | Strasbourg, France
Supplement 9.6 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 1 January 2019, and to follow the instructions given in the document.
Certification of suitability (CEP) / Procedure of certification (general) | Guideline | 17 July 2018 | Strasbourg, France
The EDQM document “Implementation of ICH Q3D in the Certification Procedure” has been revised based on experience gained by EDQM since the initial implementation of the policy. Its implementation date is the 1st September 2018.
EDQM / All activities | Report | 02 July 2018 | Strasbourg, France
The EDQM has released its 2017 Annual Report providing an overview of its accomplishments. Among the major highlights for the past year, the European Pharmacopoeia (Ph. Eur.) Commission kept on ensuring that the monographs and texts of the Ph.Eur. stay abreast of scientific and technological progress and achieved considerable progress in the field of biotherapeutic products. For example, the...
EDQM | News | 12 June 2018 | Metz, France
The first stone of a new secondary site for the Council of Europe’s European Directorate for the Quality of Medicines and HealthCare (EDQM) has been laid. The new site will be used to store the EDQM’s portfolio of over 3 000 pharmaceutical reference standards, as an addition to those already in stock at the main building in Strasbourg.
Certification of suitability (CEP) | News | 22 May 2018 | Strasbourg, France
EDQM has elaborated the guideline “How to read a CEP” with the aim of describing in detail the information conveyed on the Certificates of suitability to the Monographs of the European Pharmacopoeia (CEP).
Certification of suitability (CEP) / Procedure of certification (general) | News | 15 May 2018 | Strasbourg, France
Users of CEPs are invited to provide comments on draft monographs published in Pharmeuropa 30.2 before 30 June 2018.
Certification of suitability (CEP) / Inspection | News | 24 April 2018 | Strasbourg, France
As part of the Certification of Suitability procedure, the EDQM runs an inspection programme for API manufacturers and is committed to optimise the inspection resources as much as possible.