Home

New Product Filings to date

Variations and Agency Responses filed to date

Shortest time (months) to SAHPRA approval for New Medicine

Africa CDC donates equipment to SAHPRA to support regulatory functions in vaccine manufacturing10 August 2023, 11:24 am
Pretoria, 10 August 2023 – The Africa Centre for Disease Control and Prevention (Africa CDC) has today officially handed over equipment worth USD 750,000 to South African Health Products Regulatory Authority (SAHPRA) to support its regulatory functions relating specifically to vaccine manufacturing. In April 2021,... The post Africa CDC donat...
SCA Judgement Ruling2 August 2023, 12:05 pm
The South Africa Health Products Regulatory Authority (SAHPRA), in collaboration with Pharmacometrics Africa and tThe Department of Pharmacy and Pharmacology at the University of Witwatersrand, is pleased to announce the second cohort of graduates who successfully completed the short course for Clinical Assessors within African Regulatory Agencies....

SAMED engaging at the highest levels to raise medtech profile2 August 2023, 10:43 am
SAMED Chair, Peter Mehlape and other SAMED Board members have engaged in high-level discussion with the Presidency and a Cabinet minister regarding macro-political matters our government has been contending with, including international and trade relations with the United States, in recent months. Since the end of May, there were two important meet...
Port Health process flow and contact details1 August 2023, 8:23 am
The South African Health Product Regulatory Authority (SAHPRA) has developed a process flow for Port Health issues. This process of escalation is aimed at facilitating speedy resolution of Port Health challenges. The contact details of the Border Technicians are on the website under Key Contacts under Inspectorate And Regulatory Compliance / Regula...