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28 Jan

Posted at 20:41h in

This document is intended to communicate with the Holders of Certificates of Registration (HCRs) of orally administered phenylephrine-containing medicines.   Following the communication issued to stakeholders on 30 July 2024 regarding the ineffectiveness of oral phenylephrine preparations as nasal decongestants, HCRs for orally administered phenylephrine-containing medicines were...

01 Aug

Posted at 14:17h in

This document is intended to provide communication to the HCRs for orally administered phenylephrine-containing medicines.   The Advisory Clinical Committee discussed the communication from the United States Food and Drug Administration (US-FDA) regarding the efficacy of orally administered phenylephrine as a nasal decongestant. This communication emanates from...

13 Dec

Posted at 14:01h in

As you may be aware, SAHPRA has embarked on a process to digitalise its business processes. A pilot electronic process is planned for new medicinal clinical trial applications for January 2024. The official launch of the system for all new medicinal clinical trial applications will...

20 Feb

Posted at 10:08h in

This guideline is intended to provide guidance to applicants regarding applications for registering co-packaged medicines. It represents the South African Health Products Regulatory Authority (SAHPRA) current thinking on co-packaging of medicines. SAHPRA reserves the right to request any additional information to establish the safety,...