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South Africa's SAHPRA's Clinical Guideline for Human Medicines Registration
The registration of human medicines is a complex process that requires comprehensive scientific evidence demonstrating that a product is safe, effective, and manufactured to acceptable quality standards. To support applicants seeking registration of human medicines in South Africa, SAHPRA has issued the guidance Clinical Guideline. The guideline provides detailed information on the clinical evaluation pathways available for human medicines and outlines the documentation, dat
Sharan Murugan
Jun 64 min read
European Commission: Health Technology Assessment -Guidance on Outcomes for Joint Clinical Assessments and Reporting Requirements
The European Commission has recently published two new guidance documents on Health Technology Assessment (HTA), dated June 13, 2024....
Sharan Murugan
Jun 23, 20242 min read