eCTD submission

EMA launches PSUR Repository to facilitate assessment of medicines safety reports

An electronic repository for periodic safety update reports (PSURs) and their assessment reports was launched by the European Medicines Agency (EMA). The central platform was created in accordance with the pharmacovigilance legislation of the European Union (EU) and will contain all information related to PSURs in the EU. It will facilitate the assessment of PSURs by medicines regulatory authorities in the EU.

http://esubmission.ema.europa.eu/psur/psur_repository.html

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