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Sharan Murugan
Nov 19, 20231 min read
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...
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Sharan Murugan
Jun 18, 20231 min read
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...
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Sharan Murugan
Jun 6, 20231 min read
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...
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Sharan Murugan
May 21, 20231 min read
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...
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Sharan Murugan
May 9, 20231 min read
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...
107 views1 comment
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Sharan Murugan
Apr 29, 20231 min read
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...
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Sharan Murugan
Mar 8, 20231 min read
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...
65 views0 comments
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Sharan Murugan
Nov 27, 20221 min read
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...
61 views0 comments
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Sharan Murugan
Oct 3, 20221 min read
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)...
279 views0 comments