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Patient & Consumer Protection | News | 13 June 2019 | Strasbourg, France
The European Commission has issued its final legally binding decision on medicines containing valsartan, candesartan, irbesartan, losartan and olmesartan on 2 April 2019. This decision was based on the scientific assessment of angiotensin-II-receptor antagonists (sartans) containing a tetrazole group performed by the Committee for Medicinal Products for Human Use (CHMP), the conclusions of which...
EDQM / All activities | News | 06 June 2019 | Strasbourg, France
The latest EDQM Annual Report provides an overview of its accomplishments. In 2018 much was accomplished in the field of setting quality standards for the manufacture and control of medicines in Europe and beyond.
European network of OMCLs / General European OMCLs Network activities | News | 03 April 2019 | Strasbourg, France
Since the start of the sartan crisis in summer 2018, OMCLs of the European Network have elaborated a number of test methods to qualify and quantify nitrosamines in Active Pharmaceutical Ingredients (APIs) and drug products of the sartan group. While at the beginning, work focused on the two major reported contaminants, N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA), laboratories...
European network of OMCLs / General European OMCLs Network activities | News | 27 March 2019 | Strasbourg, France
The number of centrally authorised medicines tested every year has steadily increased from nine in the 1997-1998 pilot project to 58 in 2017, totalling over 700 products. Most of the issues identified during the testing resulted in EMA requiring companies to amend the registered manufacturer’s control methods for their medicines. In a small number of cases, the tested samples were not compliant...