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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

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

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