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Sharan Murugan
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...
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Sharan Murugan
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...
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Sharan Murugan
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...
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Sharan Murugan
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...
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