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EMA GVP Module VII – Explanatory Note (Rev. 4): Periodic Safety Update Report (PSUR) Single Assessment
The European Medicines Agency (EMA) has issued Revision 4 of the "Explanatory Note to Good Pharmacovigilance Practices (GVP) Module VII – Periodic Safety Update Report" prepared by the Human Medicines Evaluation Division. This revision addresses practical challenges encountered during the PSUR Single Assessment (PSUSA) process, particularly for nationally authorised medicinal products (NAPs), and serves as the basis for the forthcoming update of GVP Module VII. Purpose of the
Sharan Murugan
10 hours ago3 min read