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May 8, 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....

Mar 6, 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...

Oct 19, 20211 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...

Sep 17, 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,...