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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...

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...

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...

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...

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...

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...

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...

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...

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)...