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-PEM-BIO-02_v5-Biosimilar Medicines Quality Non-Clinical and Clinical Requirements | Guideline amendment to address the interchangeability of biologicals with biosimilars for industry comment. | 20 March 2025 | 30 May 2025 | biologicals@sahpra.org.za | Download Form | Download Document for Comment |