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....
Following the Engagement Portal webinar of 26 August 2026, this communication sets out the key activities and dates for the two programmes that sit with Health Products Authorisation (HPA) and confirms the requirements for their completion....
In the communication dated 30 July 2026 (COMM Issue No. CLINPR_06_2026_27_Final.pdf), SAHPRA notified all Holders of Certificates of Registration (HCRs) of the final regulatory position regarding orally administered phenylephrine-containing medicines. HCRs were required to notify SAHPRA in writing of their chosen pathway (effectiveness study or...
This letter serves to officially inform the industrial radiography community SAHPRA has decided to discontinue the following processes within its regulatory operations with immediate effect: Registration of Industrial Radiographers Conducting Examinations for Radiation Protection Officers (RPO) ...
The South African Health Products Regulatory Authority (SAHPRA) invites all stakeholders to participate in a survey on the advertising of medicines in South Africa. SAHPRA is mandated by the Medicines and Related Substances Act, 1965 (Act 101 of 1965), to regulate medicines, scheduled substances and...
The South African Health Products Regulatory Authority (SAHPRA) calls on industry stakeholders to verify their records and identify any variation applications that may have been submitted but remain unprocessed due to the transition to the new system. The applications that may have been affected were...