This document intends to provide clarity on SAHPRA’s Core Business Escalation procedure, to enable effective and efficient communication between SAHPRA and its stakeholders....
Applicants are advised to submit clinical trial applications before the due date. Applicants submitted after the due date will not be accepted....
SAHPRA requests electronic submission of the latest PSMF by 12 November 2025, including PV staffing details and a list of registered and marketed products. Submit via email to GVP@sahpra.org.za with the specified subject line....
Dear Applicants, This roadmap outlines the phased implementation of unique product identification requirements for all health products in South Africa, transitioning from batch-level to unit-level serialisation across primary, secondary, and tertiary packaging levels....
The SAHPRA OTC Online Directory has been operational for some time. As outlined in the OTC Toolkit, it is mandatory to include the required lock-ins on all Schedule 0–2 promotional and advertising materials....
This communication is issued in view that SAHPRA has embarked on a process to digitalise its business processes and need to pilot the electronic process. The pilot is planned for new medicinal clinical applications for the month of October 2025, with the official launch of...
The South African Health Products Regulatory Authority (SAHPRA) would like to invite you to a Medical Dictionary for Regulatory Activities (MedDRA) training. MedDRA is an international standardised medical terminology developed to facilitate the sharing of regulatory information for medical products used by humans. This communication...
This document is intended to communicate the position of the South African Health Products Regulatory Authority (SAHPRA) on reprocessing of single use medical devices to stakeholders....
This document outlines the approach that the South African Health Products Regulatory Authority (SAHPRA) has undertaken to implement the process of the renewal of the certificate of registration for medicinal products, ensuring a consistent approach to benefit all stakeholders, thereby guaranteeing that quality, efficacious, and...
This communication is intended to provide industry stakeholders with the regulatory requirements of Artificial Intelligence and Machine Learning (AI/ML)-enabled medical devices in South Africa....