Tag: MHRA pharmacovigilance inspections

MHRA Safety Reporting Obligations in Clinical Trials

September 25, 2025

MHRA Safety Reporting Obligations in Clinical Trials Step-by-Step Guide to MHRA Safety Reporting Obligations in UK Clinical Trials Safety reporting is the backbone of pharmacovigilance in clinical trials. In the United Kingdom (UK), the Medicines and Healthcare products Regulatory Agency (MHRA) enforces strict obligations on sponsors and investigators for handling, documenting, and reporting adverse events…

Clinical Trials in UK, Country-Specific Clinical Trials

Delayed SAE Reporting as a Common Regulatory Audit Finding

August 10, 2025

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Delayed SAE Reporting as a Common Regulatory Audit Finding Why Delayed SAE Reporting Is a Frequent Regulatory Audit Concern Introduction to SAE Reporting and Its Criticality Serious Adverse Events (SAEs) represent life-threatening or medically significant occurrences in participants during a clinical trial. Regulatory frameworks such as ICH E2A, 21 CFR Part 312.32 (FDA), and EU…

Regulatory Audit Findings, Safety Reporting Audit Findings