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...
As part of implementing the Traceability Guideline on Health Products, the South African Health Products Regulatory Authority (SAHPRA)continues to engage with industry stakeholders, sector associations, and public-sector partners as the project moves from planning phase to delivery. An important part of this work is the survey...
The South African Health Products Regulatory Authority (SAHPRA) wishes to inform all pharmaceutical industry stakeholders that an amendment to Regulation 6 was published in Government Gazette No. 55152, Notice No. 7780, on 7 August 2026 for implementation. The published amendment contained two aspects: first, the...
This communication serves as a formal update to all Holders of Certificates of Registration (HCRs) of orally administered phenylephrine‑containing medicines following the consultative meeting held on 24 April 2026 and subsequent internal deliberations by the Authority....
The South African Health Products Regulatory Authority (SAHPRA) invites sponsors, applicants, Clinical Research Organisations (CROs), investigators and Holders of Certificates of Registration (HCRs) conducting clinical trials to participate in a pilot project for the electronic reporting of Serious Adverse Events through the VigiFlow module (e-reporting...
The South African Health Products Regulatory Authority (SAHPRA) invites all Holders of Certificates of Registration (HCRs) and Clinical Research Organisations (CROs) responsible for submitting adverse events (AEs) and/ or serious adverse events (SAEs) to a consultation meeting on the implementation of the Industry e-Reporting VigiFlow...