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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
23 views
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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
1 comment
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
46 views
0 comments
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
67 views
0 comments
South Africa's (SAPHRA) Guideline for Fixed-Dose Combination Products
Earlier today (07-February-2023) the South African Health Products Regulatory Authority (SAPHRA) released an updated "Guideline for...
Sharan Murugan
Feb 7, 20231 min read
29 views
0 comments
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
65 views
0 comments
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
309 views
0 comments
SAPHRA - Guideline on Availability of Medicines for Use in a Public Health Emergency (PHE)
The South African Health Products Regulatory Authority published a guideline that provides recommendations to applicants who intend to...
Sharan Murugan
May 26, 20221 min read
15 views
0 comments
SAHPRA Guidance on Pharmacovigilance Inspections for Human Medicinal Product
South African Health Products Regulatory Authority updated its guidance on Pharmacovigilance Inspections for Human Medicinal Products....
Sharan Murugan
May 8, 20221 min read
22 views
0 comments
South Africa (SAHPRA) Guidance on How to Submit Variation Applications
The purpose of this document is to inform applicants on how to submit variations to the South African Health Products Regulatory...
Sharan Murugan
Mar 6, 20221 min read
159 views
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South Africa’s (SAHPRA’s) updated Reliance Guideline for a New Registration or Variation Application
This guideline is intended to provide information and guidance to applicants/HCRs on the prescribed requirements and process to be...
Sharan Murugan
Oct 19, 20211 min read
72 views
0 comments
South Africa- Updated Guideline on Classification of Med.Dev and IVDs & Medicines for use in PHU
Updated Guideline on Classification Of Medical Devices and IVDs The aim of this guideline is to assist manufacturers, importers,...
Sharan Murugan
Sep 17, 20211 min read
16 views
0 comments