This notice provides an update regarding the continuation of the Type II Variations Pilot Submission Windows and introduces specific process enhancements....
The South African Health Products Regulatory Authority (SAHPRA) has released the updated eCTD defined lists and document matrices, effective 10 October 2026. The update includes 31 new submission types (sub-type-51 to sub-type-81) and new entries in the application type, sequence type, submission lead and evaluation...
The Authority has received requests from applicants for additional time to complete the Medicines Registry linkage and IDMP data requirements that were communicated following the Engagement Portal webinar of 26 August 2026. This notice shall be read in conjunction with Communication Issue No.: HPA18-2026/27...
The South African Health Products Regulatory Authority (SAHPRA) notifies all applicants and holders of certificates of registration that the submission window for Type II Variations Pilot Project, including related changes bundled variations submissions, has been extended to Friday, 30 October 2026....
This communication serves to notify all radiotherapy licence holders, medical physicists, and other relevant stakeholders that the new SASQART practice guideline has been implemented. The revised SASQART practice guideline seeks to establish a standardised framework for quality assurance in radiotherapy and to ensure compliance with...
The South African Health Products Regulatory Authority (SAHPRA) intends to host a workshop on clinical trials-related matters affecting both the Industry and the SAHPRA Clinical Trials Committee (CTC). ...
This document is intended to provide communication to industry and guide stakeholders on how to prepare and distribute “Dear Veterinary Professional” (DVP) letters for safety concerns associated with the use of registered veterinary medicines. It gives details on the format and content to effectively communicate...
This document provides regulatory guidance for importers, exhibitors, and other applicants seeking SAHPRA approval to import medical devices, including in vitro diagnostic medical devices (IVDs) and unlicenced listed electronic products into the Republic of South Africa for exhibition, appraisal, demonstration, or training. The Medicines and...
The National Immunisation Safety Expert Committee (NISEC), formerly a National Department of Health (NDoH) Ministerial Advisory Committee on vaccine safety, now serves as a Technical Advisory Committee within the South African Health Products Regulatory Authority (SAHPRA). This transition integrates NISEC's specialised vaccine-safety expertise into SAHPRA’s...
This document consolidates SAHPRA’s responses to questions received from industry stakeholders following its 30 July 2026 communication regarding the lack of effectiveness of oral phenylephrine as a nasal decongestant....