General ECTD & human medicines Archives - Page 5 of 9

22 Jun Communication to Industry on Nitrosamine Review for New Applications and Registered Products including Biologicals

Posted at 13:23h in

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...

13 Jun Communication on Medicines Registration Renewals Implementation Framework

Posted at 18:43h in

This document sets out the proposed approach that SAHPRA undertakes to implement the process of medicine registration renewals ensuring a consistent approach to benefit all stakeholders to ensure quality, efficacious and safe products are available to the public....

13 Jun Retention Fee Notification – 9 June 2022

Posted at 16:03h in

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...

25 May Payment of annual retention fees for registered products

Posted at 15:40h in

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...

22 Feb Priority Review Requests Communication

Posted at 19:16h in

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....

22 Feb Multiple Applications Guideline

Posted at 09:57h in

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...

Archive

22 Jun Communication to Industry on Nitrosamine Review for New Applications and Registered Products including Biologicals

13 Jun Communication on Medicines Registration Renewals Implementation Framework

13 Jun Retention Fee Notification – 9 June 2022

25 May Payment of annual retention fees for registered products

22 Feb Priority Review Requests Communication

22 Feb Multiple Applications Guideline

01 Feb Biopharmaceutics Classification System (BCS) Based Biowaiver Application Form

01 Feb Additional Strength Biowaiver Application Form

01 Feb Quality And Bioequivalence Abridged Review Template

01 Feb Bioequivalence Trial Information Form (BTIF)

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