Council for europe portal
Language : en Search
Choose language

Newsroom

Reference Standard / Chemical reference standard (CRS) | News | 16 February 2018 | Strasbourg, France
The EDQM announces the availability of a new reference standard: Sodium aminosalicylate dihydrate for equipment qualification CRS 1 replacing the former Amoxicillin trihydrate for performance verification CRS, which will be discontinued as of 1 April 2018.
European Pharmacopoeia / General | News | 16 February 2018 | Strasbourg, France
The Indian Pharmacopoeia Commission (IPC) and EDQM are pleased to announce their joint symposium on ‘Drug Standards and Regulatory Updates’ on 26 to 27 April in Mumbai, India. The programme covers the roles of the European and Indian Pharmacopoeia Commissions in the quality control of medicines and provides an overview of pharmaceutical regulatory requirements in Europe and India, as well as...
Certification of suitability (CEP) / Procedure of certification (general) | News | 06 February 2018 | Strasbourg, France
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.
Reference Standard / Chemical reference standard (CRS) | News | 01 February 2018 | Strasbourg, France
The European Directorate for the Quality of Medicines and HealthCare (EDQM) announces the availability of four new elemental impurity chemical reference standards (CRS) in its European Pharmacopoeia catalogue: lead, cadmium, mercury and arsenic.
Transplantation / Organ trafficking | News | 31 January 2018 | Strasbourg, France
Armenia has signed the Council of Europe Convention against Trafficking in Human Organs on 24 January 2018. The Convention, which is now signed by 21 countries and ratified by 5, identifies various activities constituting human organ trafficking as criminal offences and will come into force on 1 March 2018.
Certification of suitability (CEP) / Certification content of dossier | News | 29 January 2018 | Strasbourg, France
The EDQM has revised the document « Guidance for electronic submissions for Certificates of Suitability (CEPs) applications ». The requirements with regards the format of CEP submissions have been updated
Certification of suitability (CEP) / Procedure of certification (general) | News | 19 January 2018 | Strasbourg, France
Users of CEPs are invited to provide comments on draft monographs published in Pharmeuropa 30.1 before 31 March 2018.
Certification of suitability (CEP) / Procedure of certification (general) | News | 19 January 2018 | Strasbourg, France
Supplement 9.5 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 July 2018, and to follow the instructions given in the document.
European Pharmacopoeia / General text/chapter | News | 18 January 2018 | Strasbourg, France
Revision of the Ph. Eur. general chapters on plasticised PVC materials, following the 159th Commission session (November 2017) of the Ph. Eur. Commission.
Certification of suitability (CEP) / Products with risk of TSE | News | 10 January 2018 | Strasbourg, France
EDQM has revised the guideline "Content of the dossier for a substance for TSE risk assessment". The revision takes into account all recent regulatory changes in the field and a new paragraph has been added with regard to the requirements for raw materials used for medical devices.
European Pharmacopoeia / General | News | 08 January 2018 | Zagreb, Croatia
The EDQM is pleased to announce that registration for the European Pharmacopoeia (Ph. Eur.) training session is now open. The event will take place on 24 to 25 May in Zagreb (Croatia).
Products and Services | News | 02 January 2018 | Strasbourg, France
Pharmeuropa contains draft pharmacopoeial texts for which the European Pharmacopoeia Commission is seeking comment.
Products and Services | News | 15 December 2017 | Strasbourg, France
The 9.5 supplement of European Pharmacopoeia is now available and will be applicable in 38 European countries as from 01 July 2018.
European Pharmacopoeia / Ph. Eur. Commission | News | 07 December 2017 | Strasbourg, France
The EDQM wishes to inform stakeholders that the monograph for Etanercept (2895) will be published in the Supplement 9.5 of the European Pharmacopoeia and will become effective on 1 July 2018.
European Pharmacopoeia / Ph. Eur. Commission | News | 28 November 2017 | Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) Commission adopted 11 new monographs at its 159th Session, which took place in Strasbourg on 21-22 November 2017.