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16 Jul Contact Details for Guideline SAHPGL-MD-03 Medical Device Vigilance: Adverse Events Reporting for License Holders

Posted at 15:01h in

This document is intended to provide contact details for communicating reportable adverse events, as per Guideline SAHPGL-MD-03, as well as contact details for any Recalls and Market actions for medical devices (including IVDs). Reportable adverse event reports must be emailed to: mdvigilance@sahpra.org.za....

15 Jul The value of a structured, systematic approach to benefit-risk assessment of medicines – SAHPRA case study

Posted at 14:05h in

This study investigates the utility of the Universal Methodology for Benefit-Risk Assessment (UMBRA) framework within the South African Health Products Regulatory Authority (SAHPRA) to determine whether adopting a structured approach improves consistency, transparency, and quality in benefit-risk assessments of new chemical entities (NCEs). The UMBRA...

14 Jul Communication to Industry – SAHPRA Engagement Portal – Launch Updates (14 July)

Posted at 20:56h in

Dear Applicants, As we progress with the South African Health Products Regulatory Authority (SAHPRA) Portal implementation – we note several enquiries submitted by organisations as individual emails and escalated one by one. This unfortunate tactic has now severely bottlenecked the support desk email address, and applicants who have been...

09 Jul Policy Position of the South African Health Products Regulatory Authority on Enabling Local Manufacturing

Posted at 15:52h in

During the last decade, promoting sustainable access to quality and affordable medicines has been of significant concern to African leaders. More recently the opportunity to promote local, regional and continental production of the medicines needed is considered as part of the overall health systems strengthening...

30 Jun Communication to Industry – Variations Communication

Posted at 16:13h in

Normal submission of Type IA & IAIN, IB, II The South African Health Products Regulatory Authority (SAHPRA) allows for variation submissions as follows: Type IA variations (inclusive of Type IAIN): a maximum of three (3) type IA variation changes (unrelated or related) is applicable for a...

24 Jun Report for Monitoring and Advertising of Promotional Material

Posted at 14:10h in

The role of the South African Health Products Regulatory Authority (SAHPRA) regarding advertising and marketing of medicines....

23 Jun Regulatory Requirements for Veterinary Medical Devices (Including in-vitro Diagnostic Veterinary Medical Devices)

Posted at 11:17h in

The Medicines and Related Substances Act, 1965 (Act 101 of 1965) as amended, read in conjunction with the General Regulations on Medical Devices, published in Government Gazette Notice 40480, No.1515 of 9 December 2016, provides for the regulatory oversight of veterinary medical devices including In-Vitro...

13 Jun Regulatory Information Management System – Technical Files – Website Upload

Posted at 15:04h in

The South African Health Products Regulatory Authority (SAHPRA) has issued important updates impacting the technical files located in the SAHPRA eCTD repository and found in the following location, SAHPRA eCTD....

11 Jun Pseudoephedrine-containing medicines – Risks of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS)

Posted at 14:46h in

Haleon South Africa (SA), in collaboration with the South African Health Products Regulatory Authority (SAHPRA), would like to inform you about the risks of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) associated with the use of pseudoephedrine-containing medicines....

10 Jun Communication to Industry – SAHPRA Updates Regarding the Use of Yohimbine in Veterinary Medicine

Posted at 16:05h in

This communication to industry was developed to express SAHPRA’s view that the therapeutic use of yohimbine in animals may be in the public interest and to outline the steps that SAHPRA is taking to place the product in the schedules....

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