Documents For Comments

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 NameDescriptionDate PublishedComments Deadline dateSubmit toComments FormDocument for Comment
SAHPGL-INSP-10 - Guideline on Regulatory Enforcement Actions for the Pharmaceutical IndustryThis Guideline provides a framework for regulatory enforcement actions in the pharmaceutical industry. It outlines steps from identifying non-compliance to applying corrective measures, enforcement actions, withdrawals and escalations. The process ensures regulatory that are risk-based, proportionate, transparent, and consistent.04 May 202604 August 2026inspectorate@sahpra.org.zaDownload comment FormDownload Document