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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.
European Pharmacopoeia / Monograph | News | 10 August 2018 | Strasbourg, France
The monograph for Octreotide (2414) – adopted by the Ph. Eur. Commission at its 160th Session in March 2018 – will not be published in Ph. Eur. Supplement 9.7 (publication date October 2018).
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.
Transfusion / Projects | News | 08 August 2018 | Strasbourg, France
The EDQM is pleased to announce it is organising a symposium on ‘Plasma Supply Management’ in Strasbourg (France) on 29-30 January 2019. This symposium will discuss the facts and scientific evidence surrounding the collection of plasma for fractionation and the elaboration of donor eligibility criteria to ensure donor protection.
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.
European Pharmacopoeia / Monograph | News | 17 July 2018 | Strasbourg, France
Pharmeuropa contains draft pharmacopoeial texts for which the European Pharmacopoeia Commission is seeking comment. If you would like to receive e-mail alerts when an issue is complete, please register for Pharmeuropa online. Pharmeuropa issue 30.3 is now complete. Deadline for comments: 30 September 2018.
Products and Services | News | 17 July 2018 | Strasbourg, France
Lead solution CRS , cadmium solution CRS, mercury solution CRS and arsenic solution CRS have been recently added in EDQM RS Portfolio. These “Class 1” elements occurring in nature are amongst the greatest potential sources of elemental contamination in medicinal products and substances for pharmaceutical use and require evaluation during the risk assessment across all potential sources of...
Anti-Counterfeiting activities / Counterfeit/illegal medical products | News | 16 July 2018 | Strasbourg, France
This project will favour better interaction between the analytical and enforcement actors involved in the fight against falsified medicines and medical devices.
Products and Services | News | 13 July 2018 | Strasbourg, France
The catalogue of the European Pharmacopoeia (Ph. Eur.) offers a portfolio of more than 2 800 reference standards. It is updated on a daily basis and gives access to all the Ph. Eur. reference standards and to Batch Validity Statement (BVS), Safety Data Sheets, leaflets.
European Pharmacopoeia / Announcements | News | 10 July 2018 | Strasbourg, France
The 9.6 supplement of European Pharmacopoeia is now available and will be applicable in 38 European countries as from 01 January 2019.
European Pharmacopoeia / Monograph | News | 10 July 2018 | Strasbourg, France
The new monograph on Sulfobutylbetadex sodium (2804) was published in Supplement 9.6 of the European Pharmacopoeia.