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Apr 17, 20232 min read

Ireland's HPRA: Guide to SAR /Event Reporting for Human Organs Intended for Transplantation

Earlier today (17-April-2023) he Health Products Regulatory Authority (HPRA) of Ireland updated its guidance on "Guide to Serious Adverse...

Apr 2, 20231 min read

Japan's PMDA: Reporting ADR & Defects during Clinical Trials using e-Application Data System

Recently Japan's the Ministry of Health, Welfare and Labour (MHLW) - Pharmaceuticals and Medical Devices Agency issued guidance “System...

Sep 1, 20221 min read

Singapore HSA: Safety Alert for Finasteride and Potential Risk of Suicidal iIdeation

The Singapore Health Sciences Authority (HSA) published a Safety Alert for Finasteride on 30-August-2022. Suicidal ideation is a known...

Jun 18, 20221 min read

South Africa SAPHRA - Post-marketing Reporting of Adverse Drug Reaction

The South African Health Products Regulatory Authority (SAPHRA) did a few Administrative updates and amendments in its Post-marketing...