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South Africa's (SAPHRA): Questions And Answers Licensing Of Medical Device Establishments
Last Friday (17 November 2023) the South African Health Products Regulatory Authority (SAPHRA) released updated guidance on "Guideline On...
Sharan Murugan
Nov 19, 20231 min read
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South Africa's (SAPHRA): Renewal Of Human Medicines Requirements and Process
Earlier today (09 June, 2023) the South African Health Products Regulatory Authority (SAPHRA) released an updated guideline on "Renewal...
Sharan Murugan
Jun 18, 20231 min read
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South Africa's (SAPHRA): Guideline on Pharmacovigilance Systems
Earlier today (06 June, 2023) the South African Health Products Regulatory Authority (SAPHRA) released an updated Guideline on...
Sharan Murugan
Jun 6, 20231 min read
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South Africa's SAPHRA: Updated Medicines Application Form Module 1.2.1
Recently (18 May 2023) the South African Health Products Regulatory Authority (SAPHRA) released an updated Application form template...
Sharan Murugan
May 21, 20231 min read
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South Africa's SAPHRA: Validation Template For ECTD Variation Applications, QOA & QIS
Recently (05 May 2023) the South African Health Products Regulatory Authority (SAPHRA) released the template "Validation Template For...
Sharan Murugan
May 9, 20231 min read
113 views
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South Africa: Information Guideline and Quality and Bioequivalence guidelines Aligning with EMA/ICH
Recently (24 April 2023) the South African Health Products Regulatory Authority (SAPHRA) released an updated "General Information...
Sharan Murugan
Apr 29, 20231 min read
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SAPHRA Guideline: Questions And Answers Licensing Of Medical Device Establishments
Recently this week the South African Health Products Regulatory Authority (SAPHRA) released an updated "Guideline On Questions And...
Sharan Murugan
Mar 8, 20231 min read
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South Africe SAPHRA Guideline: For the API Master File (APIMF) Procedure
Recently last week the South African Health Products Regulatory Authority (SAPHRA) released an updated "Guideline for the API Master File...
Sharan Murugan
Nov 27, 20221 min read
62 views
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SAPHRA (ECTD & Human Medicines Unit): Variation Communication Guideline
South African Health Products Regulatory Authority (SAHPRA) on 30 September 2022, released updated guidance on " Business As Usual (BAU)...
Sharan Murugan
Oct 3, 20221 min read
295 views
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