European Medicines Agency Watch [to 16 May 2015]
:: Safety monitoring of medicines: EMA to screen medical literature for 400 active substance groups
New service will improve safety monitoring of medicines and simplify pharmacovigilance activities for companies
The European Medicines Agency (EMA) has published the list of active substances and a reference to the journals that will be covered by its new medical literature monitoring service. This service will start with a limited number of active substances on 1 July 2015 and will be fully rolled out in September 2015. A guide, a training video and a document detailing the inclusion and exclusion criteria to be used when screening the literature are also available on a dedicated webpage.
Medical literature is an important source of information on suspected adverse reactions reported on medicines. The European Union’s (EU) pharmacovigilance legislation has given EMA responsibility for the monitoring of selected medical literature for a defined list of active substances used in medicines and for entering identified reports of suspected adverse reactions in EudraVigilance, the EU adverse drug reaction collection and management system…