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Certification of suitability (CEP) / Procedure of certification (general) | News | 15 October 2018 | Strasbourg, France
The revised EDQM ‘Guideline on requirements for revision/renewal of Certificates of Suitability to the European Pharmacopoeia Monographs’ (PA/PH/CEP (04) 2 7R) will enter into force in January 2019. Notable changes include the classification of changes related to the introduction of a new manufacturer of a starting material (see page 7), explicit reference to recent changes in the regulatory...
Transplantation / Donation Campaigns & European Organ Donation Day (EODD) | News | 12 October 2018 | Strasbourg, France
Organ transplantation is one of the great medical success stories of the 20th century, over the past few decades it has improved the quality of life of hundreds of thousands of patients. The most recent data show that more than 144 000 patients are waiting for a transplant in Council of Europe member states, and each day, 18 patients on waiting lists die waiting for an organ that never arrived...
European network of OMCLs | News | 11 October 2018 | Strasbourg, France
Today the first method for simultaneous determination of NDMA and NDEA in Sartan tablets, developed and validated for Valsartan tablets has been released by the German OMCL in Karlsruhe.
Certification of suitability (CEP) / Procedure of certification (general) | News | 09 October 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 | 09 October 2018 | Strasbourg, France
Supplement 9.7 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 April 2019, and to follow the instructions given in the document.
European Pharmacopoeia / Biologicals | Press release | 08 October 2018 | Strasbourg, France
The EDQM is the Directorate of the Council of Europe responsible for supporting the basic human right of access to good quality medicines and health care in Europe. With its European Pharmacopoeia (Ph. Eur.), the EDQM sets requirements for the quality of medicines, including those in the field of Gene Therapy Products (GTPs).
Transplantation / Cell | News | 27 September 2018 | Strasbourg, France
This publication aims at providing clear, accurate and balanced information to women about the donation of oocytes (also known as egg cells).
Products and Services | News | 27 September 2018 | Strasbourg, France
The 9.7 supplement of European Pharmacopoeia is now available and will be applicable in 38 European countries as from 01 April 2019.
Transplantation / Publications / Transplant Newsletter | News | 21 September 2018 | Strasbourg, France
The Newsletter Transplant summarises comprehensive data provided by national focal points designated by governments on donation and transplantation activities.
European network of OMCLs | News | 21 September 2018 | Strasbourg, France
Since early July 2018, OMCLs have been involved in investigations and actions to address the issues related to the detection of N-nitrosodimethylamine (NDMA) in valsartan. The Network has meanwhile developed methods for the specific testing of nitrosamines in sartans on the basis different analytical principles.
European Pharmacopoeia / General | News | 18 September 2018 | Strasbourg, France
The EDQM has provided a platform for European and international medicine manufacturers to discuss new regulatory approaches in China on pharmaceutical excipients selection and quality control. During a workshop on 18 September in Strasbourg, the Chinese Pharmacopoeia (ChP) delivered the most complete picture of their roadmap on the quality of excipients in China. The ChP illustrated the...
European network of OMCLs | News | 14 September 2018 | Strasbourg, France
The EDQM continues investigating and defining actions to address the presence of all kinds of nitrosamines, including NDMA and NDEA in valsartan and other sartans which may be affected. As mentioned in a previous press release, the EDQM has contacted those manufacturers holding CEPs (Certificates of Suitability to the monographs of the European Pharmacopoeia) and whose substances may present a...
Products and Services | News | 07 September 2018 | Strasbourg, France
9 new Ph. Eur. Reference Standards (RS) were released in August 2018
Certification of suitability (CEP) | News | 28 August 2018 | Strasbourg, France
The EDQM is continuing the investigations and actions which started in July 2018 to address the issue related to the detection of N-nitrosodimethylamine (NDMA) in a source of active substance valsartan.
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).