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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...

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...

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...

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...

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...

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...

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...

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...

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)...