Clinical Evaluations Management Archives

22 Sep Guideline for Selection of Reference Products for Applications of Generic Medicines

Posted at 11:38h in

This document guides applicants who seek to apply for new registration of generics supported by Bioequivalence studies. The South African Health Products Regulatory Authority (SAHPRA) can request additional information to establish whether the health products meet the safety, quality and performance standards. While other approaches...

15 Sep SAHPRA Integrates the National Immunisation Safety Expert Committee (NISEC) into its Governance and Administrative Framework

Posted at 14:41h in

The National Immunisation Safety Expert Committee (NISEC), formerly a National Department of Health (NDoH) Ministerial Advisory Committee on vaccine safety, now serves as a Technical Advisory Committee within the South African Health Products Regulatory Authority (SAHPRA). This transition integrates NISEC's specialised vaccine-safety expertise into SAHPRA’s...

04 Sep Frequently Asked Questions (FAQ) – Oral Phenylephrine-Containing Products

Posted at 10:56h in

This document consolidates SAHPRA’s responses to questions received from industry stakeholders following its 30 July 2026 communication regarding the lack of effectiveness of oral phenylephrine as a nasal decongestant....

28 Aug Extension of Notification Deadline – Oral Phenylephrine Pathway Selection

Posted at 18:08h in

In the communication dated 30 July 2026 (COMM Issue No. CLINPR_06_2026_27_Final.pdf), SAHPRA notified all Holders of Certificates of Registration (HCRs) of the final regulatory position regarding orally administered phenylephrine-containing medicines. HCRs were required to notify SAHPRA in writing of their chosen pathway (effectiveness study or...

11 Aug Phenylephrine – Lack of Effectiveness of Oral Preparations as Nasal Decongestants

Posted at 09:32h in

This communication serves as a formal update to all Holders of Certificates of Registration (HCRs) of orally administered phenylephrine‑containing medicines following the consultative meeting held on 24 April 2026 and subsequent internal deliberations by the Authority....

28 Jul Pharmacovigilance and Clinical Trials Units | SAHPRA Industry Consultation on e-Reporting VigiFlow Platform

Posted at 12:36h in

The South African Health Products Regulatory Authority (SAHPRA) invites all Holders of Certificates of Registration (HCRs) and Clinical Research Organisations (CROs) responsible for submitting adverse events (AEs) and/ or serious adverse events (SAEs) to a consultation meeting on the implementation of the Industry e-Reporting VigiFlow...

04 Jun Pilot: Clinical Trial Applications Electronic System – Update

Posted at 09:50h in

SAHPRA has embarked on a process to digitalise its business processes. A pilot electronic process is in progress for new medicinal clinical trial applications from April 2026 and so far included May and June 2026 submission due dates....

01 Jun Guideline for Submission of Extension Applications

Posted at 09:03h in

This guideline is intended to provide guidance to applicants who intend to submit extension applications for registration. It represents the South African Health Products Regulatory Authority’s (SAHPRA) current position on the safety, quality and efficacy of these medicines. ...

07 May Bioequivalence studies performed by Contract Research Organisation (Raptim Research Pvt. Ltd)

Posted at 18:49h in

This document is intended to communicate the South African Health Products Regulatory Authority’s (SAHPRA’s) position to all Applicants/ Holders of Certificates of Registration (HCRs) who intend to submit/ have submitted applications supported by bioequivalence studies conducted by Raptim Research Pvt. Ltd, a Contract Research Organisation...

01 Apr Phenylephrine – Lack of Effectiveness of Oral Preparations as Nasal Decongestant: Extension of Deadline for Written Submissions and Updated Meeting Date

Posted at 21:20h in

The South African Health Products Regulatory Authority hereby issues an update to all Holders of Certificates of Registration (HCRs) of orally administered phenylephrine-containing medicines, following the communication dated 23 March 2026. Download previous version ...

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