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Single, central platform now mandatory for all periodic safety update reports.

Source :
Medical Writing; Sep2016, Vol. 25 Issue 3, p56-57, 2p
Publication Year :
2016

Abstract

The article focuses on the periodic safety update report (PSUR) repository developed by agency for protection of public and animal health through supervision of medicines European Medicines Agency in collaboration with European Union (EU) Member States and industry. It discusses the single storage platform for PSURs and related documents to be used by all regulatory authorities and pharmaceutical companies in the EU. It mentions its introduction by the EU pharmacovigilance legislation.

Details

Language :
English
ISSN :
20474806
Volume :
25
Issue :
3
Database :
Complementary Index
Journal :
Medical Writing
Publication Type :
Academic Journal
Accession number :
119025577