EMA UPDATES ADVICE ON PERIODIC MEDICINE SAFETY
January 7th, 2015
THE EUROPEAN Medicines Agency (EMA) has updated procedural guidance on how pharmacos should make periodic safety update reports (PSURs) about approved medicines. Their aim is to take account of patient monitoring and side effects to improve safety advice about pharmaceuticals. Until now, proposed changes to product information required submission of tracked-changes versions of all national product data covered by a particular PSUR. Under a new system, piloted by EMA from this month (January), a simplified approach for reporting such new information can be used. ...
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