EMA TO Open UP Article 57 Pharmacovigilance Database to Simplify Regulatory Changes
This article was originally published in SRA
Executive Summary
The European Medicines Agency will soon open up its database to national competent authorities to give them access to information on the qualified person for pharmacovigilance (QPPVs) and the location of pharmacovigilance system master file (PSMF) for each drug authorized in the EU. Once this happens there will be no need for drug companies to submit variation applications with regard to changes on these fronts1.