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South Africa SAHPRA’s Guidelines: for Labelling of Medicines Intended for Human Use and Adverse Drug Reactions (ADRs) Reporting
The South African Health Products Regulatory Authority (SAHPRA) plays a pivotal role in safeguarding public health by ensuring medicines are safe, effective, and properly labelled, and by maintaining robust pharmacovigilance through adverse drug reaction (ADR) reporting. In its continuous mission to strengthen medicine safety and promote patient wellbeing, the SAHPRAÂ has issued two crucial documents: The Guideline for Labelling of Medicines Intended for Human Use , and The Gu

Sharan Murugan
Nov 12 min read
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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...

Sharan Murugan
Apr 17, 20232 min read
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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...

Sharan Murugan
Apr 2, 20231 min read
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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...

Sharan Murugan
Sep 1, 20221 min read
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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...

Sharan Murugan
Jun 18, 20221 min read
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