This document specifies Module 1 and the regional sections 2.3.R/3.2.R of the electronic 2 Common Technical Document (eCTD) for South Africa (“ZA”)....
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: SAHPRA Renewal Process Flow...
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....
This guideline is intended to provide recommendations to applicants wishing to submit multiple applications for the registration of medicines. It represents the South African Health Products Regulatory Authority’s (SAHPRA) current thinking on the safety, quality and efficacy of medicines. It is not intended as an...
2022 Aug...