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 |
|---|---|---|---|---|---|---|
| SAHPGL_INSP_10 - Guideline on Regulatory Enforcement Actions for the Pharmaceutical Industry | The guideline above delineates the mandatory regulatory framework of the Radiation Control Inspectorate sub-unit comprising of inspection-related requirements for all Group III and Group IV Hazardous Substances, according to the Hazardous Substance Act 15 of 1973 and Regulations R1332 and R247. | 13 April 2026 | 13 July 2026 |
| Download comment Form | Download Document for Comment |
| SAHPGL-RDN-INSP-03 - Guideline on Minimum Requirements for performing Inspections of Group III and Group IV Hazardous Substances | The guideline above delineates the mandatory regulatory framework of the Radiation Control Inspectorate sub-unit comprising of inspection-related requirements for all Group III and Group IV Hazardous Substances, according to the Hazardous Substance Act 15 of 1973 and Regulations R1332 and R247. | 25 March 2026 | 25 April 2026 |
| Download comment Form | Download Document for Comment |
| SAHPGL-CEM-PV-08 - Guideline for Industry e-Reporting | This document serves as a guideline for those reporting adverse drug reactions. It represents the South African Health Products Regulatory Authority’s (SAHPRA)’s current thinking on the safety, quality and efficacy of medicines. | 12 March 2026 | 12 April 2026 |
| Download comment Form | Download Document for Comment |
| Guideline for the Completion of the Annual Submission of Compliance Information Form | The objective of this guideline is to give clear guidance on the Annual Submission of Compliance Information process from the perspective of an importer/ License Holder and Completion of the Annual submission of Compliance Information Form (OF-RDN-NM-06A, replacing Old Form: 41BM-2). | 10 March 2026 | 10 April 2026 |
| Download comment Form | Download Document for Comment |
| Guideline for Priority Review of Health Product and Only Type II Variation Applications | This guideline is intended to provide information on the request for priority review of new health products and only type II variation applications. | 25 February 2026 | 30 April 2026 |
| Download comment Form | Download Document for Comment |
| Guideline for Selection of a Reference Product for Generic Medicine Applications | The guideline recommends the selection of a reference product for generic medicine applications for new registration | 05 January 2026 | 30 April 2026 |
| Download comment Form | Download Document for Comment |