Author Archives: European Medicines Agency
Companies that make sartan blood pressure medicines (also known as angiotensin II receptor blockers) are being required to review their manufacturing processes so that they do not produce nitrosamine impurities. Companies will have a transition period to make any necessary changes, during which strict temporary limits on levels of these impurities will apply. After this period, companies will… Read More »
The European Medicines Agency (EMA) is expanding its review of impurities in valsartan following the detection of very low levels of N-nitrosodiethylamine (NDEA) in another active substance, losartan, made by Hetero Labs in India. As a result of the detection of this impurity by German authorities, the review will now include medicines containing four other ‘sartans’, namely candesartan,… Read More »
The European Medicines Agency (EMA) has published a detailed response to the European Ombudsman’s questions related to the redaction of certain elements of clinical study reports for the medicine Humira. In a letter dated 27 October 2014, the Ombudsman requested EMA to explain why it had redacted certain information in response to an access to documents request that… Read More »
Micro-, small- and medium-sized enterprises (SMEs) are making better use of the various regulatory tools that the European Medicines Agency’s (EMA) has put in place to support them during the development of their medicines. In addition, between 2011 and 2014, 62% of SME applications for marketing authorisation were granted a positive opinion by EMA’s Committee for Medicinal Products… Read More »