Pretoria, 25 June 2026 - Since its establishment in 2018, the South African Health Products Regulatory Authority has maintained a strong focus on patient safety as a central pillar of its mandate. In terms of the Medicines and Related Substances Act, 1965 (Act 101 of...
The South African Health Products Regulatory Authority (SAHPRA) hosted a webinar on the Introduction of Import Authorisation Requirements for Health Products Importers. As part of aligning with WHO Global Benchmarking Tool (GBT) Maturity Level 3 (ML3), the SAHPRA is introducing a mandatory Import Authorisation System for all health...
The South African Health Products Regulatory Authority (SAHPRA) hosted the Regulatory Technical Forum (RTF) Meeting. Areas of discussion on the agenda included: Veterinary Medicines Medical devices & IVDs Complementary medicines Medicines (Allopathic) Inspectorate Updates Inspectorate and Regulatory Compliance Legislation/Guidelines for Comment/Implementation IT Upgrade Recording ...
Pretoria, 03 June 2026 – The South African Health Products Regulatory Authority (SAHPRA) convened its quarterly stakeholder engagement session with “captains of industry” in Johannesburg on 14 May 2026. The meeting forms part of a structured programme of quarterly engagements that SAHPRA has maintained since...
Pretoria, 23 May 2026 – The South African Health Products Regulatory Authority (SAHPRA), in collaboration with the South African Pharmacy Council (SAPC), has intensified enforcement action against the unlawful manufacturing and distribution of unregistered GLP-1 and GIP medicines containing either Semaglutide, Tirzepatide, or a combination...
The South African Health Products Regulatory Authority (SAHPRA) hosted a stakeholder engagement webinar focused on medical device licensing and compliance requirements. The purpose of the engagement was to provide targeted training to industry stakeholders on SAHPRA’s regulatory requirements, supporting improved compliance and effective implementation across the...
The South African Health Products Regulatory Authority (SAHPRA) held the official online launch of the Prescription-Only Medicines (Rx) Section of the SAHPRA Online Medicines Directory. SAHPRA had previously successfully launched the Over-the-Counter (OTC) Online Medicines Directory in June 2022 as the first phase of this initiative. The...
The South African Health Products Regulatory Authority (SAHPRA) hosted a workshop on the Medical Devices Voluntary Product Registration Feasibility Study – Phase Two. The purpose of the workshop was to engage stakeholders and discuss the Expression of Interest (EOI) process for participation in the voluntary Phase...
The South African Health Products Regulatory Authority (SAHPRA) hosted an engagement session focused on training and guidance regarding SAHPRA’s requirements for Adverse Event reporting. The purpose of the engagement was to enhance industry understanding and facilitate the effective implementation of Regulation 17 of the Regulations Relating...
The South African Health Products Regulatory Authority (SAHPRA) hereby invites industry stakeholders to a consultative meeting aimed at receiving updates and feedback from applicants on the functionality of the Digital CTF1 Application Module. The purpose of this engagement is to provide a platform for industry to share...
