This guide is intended to provide guidance to applicants on Good Review Practices. It represents the South African Health Products Regulatory Authority’s current thinking on the safety, quality and efficacy of medicines and the safety, quality and performance of medical devices. It is not intended...
Please note that the South African Health Products Regulatory has hereby extended the deadline date for comments on the Borderline Products guideline (SAHPGL-CRO-01) from the 5th of September 2022, to the 8th of November 2022....
This application form should be included in the South African Common Technical Document – Module 1 Administrative Information. The application form is to be used for an application for registration, variation or renewal of a medicinal product for Human or Veterinary use submitted to the South...
Business-As-Usual (BAU) is in the process of verifying submitted/received new medicine and variation applications. Industry is kindly requested to verify/confirm if all the applications that have been submitted to SAHPRA via BAU are being processed....
In an effort to encourage widespread access to medicines in the Southern African Development Community (SADC) region, SAHPRA invites applicants to submit Expressions of Interest (EOIs) for evaluation of applications through the Zazibona collaborative process. ...
This document is intended to provide guidance on the implementation of renewals for medicine registration. This will be a “living document” and will be updated as required. Download: Annexure 1: Renewals Process Flow Diagram...
This document is intended to provide communication to industry on nitrosamine review for all other new, in-process and registered products including biological medicines and all old medicines. This will be a “living document” and will be updated. It is important that Applicants adhere to the...
Payment of Retention Fees for the Year Ending 31 December 2022 in respect of Medicines Registered up and until 31 December 2021 and/or Various Licences...
The Medicines and Related Substances Act, 1965 (Act 101 of 1965) as amended, (“the Medicines Act”) makes provision for the payment of retention fees to the Regulatory Authority in respect of medicines, medical devices and IVDs registered and site licences issued. Further to the above, Regulation...
SAHPRA has a policy to make provision for priority review, for the assessment and registration of medicines that treat serious diseases and is of major public interest....