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Ireland's HPRA Guidance: GDP Quality Systems, GXP Regulatory Advice, and Active Substance Registration Changes
The Health Products Regulatory Authority (HPRA) has released updated guidance documents to strengthen pharmaceutical quality systems, regulatory compliance, and operational oversight across Ireland’s healthcare sector. The updated guidance documents include: Guide to Quality System for General Sale Wholesale Distributors Guide to Pre-submission Scientific and Regulatory Advice for GXP Activities Guide to Managing Changes to Registrations of Active Substance Manufacturers, Imp
Sharan Murugan
May 243 min read
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
May 243 min read
USFDA Guidance: Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations
The U.S. Food and Drug Administration (FDA) has issued Revision 1 of its guidance titled "Assessing the Effects of Food on Drugs in INDs and NDAs — Clinical Pharmacology Considerations" (May 2026), prepared by the Office of Clinical Pharmacology within the Center for Drug Evaluation and Research (CDER). This revision supersedes part of the 2022 guidance on Food-Effect Bioavailability and Fed Bioequivalence Studies and consolidates current FDA thinking on when, why, and how fo
Sharan Murugan
May 204 min read