The “Documents for Comments” area serves as a space for stakeholders to engage with SAHPRA’s regulatory processes. Your input is valuable as we strive to ensure transparency and inclusivity in our decision-making. Please take the time to review the documents and share your comments. Together, we can contribute to the continuous improvement of healthcare regulation in South Africa.
| Document Name | Description | Date Published | Comments Deadline date | Submit to | Comments Form | Document for Comment |
|---|---|---|---|---|---|---|
| Guideline For Comment – Reliance Guideline | This guideline is intended to provide recommendations to applicants wishing to submit new registration applications, as well as variations, for reliance review-based evaluation. It represents the Authority’s current thinking on the safety, efficacy and quality of medicines. It is not intended as an exclusive approach. | 02 November 2023 | 31 January 2024 at 16H00 | gontse.moutloatse@sahpra.org.za | Download form | Download Document |
| Guideline For Comment – SAHPGL-CEM-02 – Guideline For Professional Information For Human Medicines (Categories A And D) | This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of Human Medicines (categories A and D) containing specified substances. With respect to Category D medicines, the guidance provided herein is related to general content requirements. | 12 December 2023 | 31 January 2024 at 16H00 | newmedicines@sahpra.org.za | Download form | Download Document |
| Form For Comment – GLF-MD-11A – Medical Device Adverse Event Reporting Form | 21 November 2023 | 20 February 2024 at 16H00 | mdvigilance@sahpra.org.za | Download form | Download Document | |
| Guideline For Comment – SAHPGL-MD-03 – Guideline Medical Device Adverse Events Reporting | This document has been prepared to serve as a recommendation to a holder of a medical device establishment license (Licensee) / Holder of a Certificate of Registration of a medical device (including an IVD) (HCR) regarding adverse event reporting for medical devices (including IVDs), and the South African Health Products Regulatory Authority (SAHPRA) current thinking on the safety, quality and performance of medical devices. | 21 November 2023 | 20 February 2024 at 16H00 | mdvigilance@sahpra.org.za | Download form | Download Document |
| Guideline For Comment – SAHPGL-MD-11 – Guideline For Completing Medical Device Adverse Event Form | This document has been prepared to serve as a recommendation to a holder of a medical device establishment license (Licensee) / Holder of a Certificate of Registration of a medical device (including an IVD) (HCR) regarding completing a medical device adverse event form and the South African Health Products Regulatory Authority (SAHPRA) current thinking on the safety, quality and performance of medical devices. | 21 November 2023 | 20 February 2024 at 16H00 | mdvigilance@sahpra.org.za | Download form | Download Document |
| Government Notice – Approved Schedules For Cannabis | The revised schedules for Cannabis were approved by the Minister of Health and published in the Gazette for public comments with a two (2) months commenting period (starting 15 January 2024). Interested persons area invited to submit any substantiated comments or representations on the proposed update to the schedule to: Director-General of Health Private Bag X828 Pretoria 0001 | 15 January 2024 | 15 March 2024 | mihloti.mushwana@health.gov.za OR paul.tsebe@health.gov.za | N/A | Download Document |