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EMA Guideline: Good Pharmacovigilance Practices (GVP): Module III on Pharmacovigilance Inspections
Effective pharmacovigilance is essential for protecting patients and supporting the safe and effective use of medicinal products. The Guidelines on Good Pharmacovigilance Practices (GVP) provide a framework for pharmacovigilance activities in the European Union. The latest introductory cover note announces the publication of Revision 2 of Module III on Pharmacovigilance Inspections, reflecting recent changes to the applicable European pharmacovigilance legislation. Background
Sharan Murugan
Sep 133 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
Voluntary GVP Inspection on Pharma Product Registration Holders- Malaysia’s NPRA
On 29-March-2022, a guidance document titled "Malaysian Guidance Document on Voluntary Good Pharmacovigilance Practices (GVP) Inspection"...
Sharan Murugan
Apr 6, 20221 min read
EMA Guidance on GVP for PPP & Parallel EMA/EUnetHTA 21 Consultation
Guideline on Good Pharmacovigilance Practices (GVP) for Pregnancy Prevention Programs A public consultation was launched by the European...
Sharan Murugan
Mar 24, 20222 min read