Past News

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.

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...

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.

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.

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.

This project will favour better interaction between the analytical and enforcement actors involved in the fight against falsified medicines and medical devices.

The 9.6 supplement of European Pharmacopoeia is now available and will be applicable in 38 European countries as from 01 January 2019.