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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
EMA Guidance: Good Pharmacovigilance Practices (GVP) — Introductory cover note with new Addendum II and GVP Module VI Addendum II – Masking of Personal Data
The European Medicines Agency (EMA) continuously updates its Good Pharmacovigilance Practices (GVP) guidelines to enhance patient privacy...
Sharan Murugan
Jul 27, 20253 min read
UK MHRA Guidance: Exceptions and Modifications to the EU Good Pharmacovigilance Practices (GVP) for UK MAHs
The Medicines and Healthcare Products Regulatory Agency (MHRA) has released updated guidance on pharmacovigilance requirements that...
Sharan Murugan
Feb 8, 20252 min read