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SAPHRA News: Implementation of RIMS – Information on eCTD 3.1 Module 1
The South African Health Products Regulatory Authority (SAHPRA) has released a communication " Implementation of RIMS – Information on...
Sharan Murugan
Oct 27, 20242 min read
South Africa SAHPRA: eCTD Validation and Technical Screening for Renewals - Template
The South African Health Products Regulatory Authority (SAHPRA) has provided updated guidance for " ECTD Validation And Technical...
Sharan Murugan
Sep 9, 20242 min read
SAPHRA Guidance: Guideline On Co-Applicancy
The South African Health Products Regulatory Authority (SAHPRA) has released a comprehensive "Guideline on Co-applicancy". This guidance...
Sharan Murugan
Jul 20, 20241 min read
South Africa (SAPHRA): Reliance Guideline
Recently this week the South African Health Products Regulatory Authority (SAHPRA) has updated the Reliance Guideline to streamline the...
Sharan Murugan
May 18, 20242 min read
South Africa SAPHRA: Guideline For Professional Information For Human Medicines (Categories A and D) and Classification of Medical Devices and IVDs
Recently last week the South African Health Products Regulatory Authority (SAPHRA) released an updated "Guideline For Professional...
Sharan Murugan
Mar 30, 20242 min read
South Africe SAPHRA: Guidelines For Medicine Recalls – Withdrawals And Rapid Alerts
Recently last week the South African Health Products Regulatory Authority (SAPHRA) released an updated guideline "Guidelines For Medicine...
Sharan Murugan
Feb 22, 20242 min read
South Africa's (SAPHRA): Import Applications Of Electronic Devices Emitting Ionizing Radiation
Earlier today (16 January, 2024) the South African Health Products Regulatory Authority (SAPHRA) released an updated Guideline For...
Sharan Murugan
Jan 16, 20241 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...
Sharan Murugan
Nov 19, 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...
Sharan Murugan
Jun 18, 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...
Sharan Murugan
Jun 6, 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...
Sharan Murugan
May 21, 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...
Sharan Murugan
May 9, 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...
Sharan Murugan
Apr 29, 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...
Sharan Murugan
Mar 8, 20231 min read
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
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
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
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
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
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