Clinical Evaluations Management Archives

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 ...

01 Apr E2B Standard as Acceptable Method of Reporting SAEs Occurring During Clinical Trial Conduct to SAHPRA

Posted at 16:02h in

This document is intended to provide communication to various stakeholders conducting Clinical Trials on allowed method for Serious Aderse Events (SAE) reporting to SAHPRA....

30 Mar Application Form: Rescheduling of a Substance or Medicine

Posted at 11:23h in

The applicant is to ensure that all relevant fields are completed on the application form and that all supporting documentation is attached. Incomplete applications will be identified as deficient, and the evaluation review will not be progressed until deficiencies are addressed. A completed application...

30 Mar Guidelines to Clinical Trials in Pregnancy and Lactation

Posted at 09:11h in

This document has been prepared as a guideline for preparing applications to conduct clinical trials in South Africa. It represents the South African Health Products Regulatory Authority’s (SAHPRA) current thinking on pregnancy and lactation for clinical research in South Africa. It is not intended as...

30 Mar Pre-clinical Testing Guidelines and Clinical Requirements for Phase I / First in Human (FIH) Studies

Posted at 09:08h in

This document has been prepared to serve as a guideline for the preparation of applications to conduct first-in-human (FIH) and Phase I clinical trials in South Africa. It is not intended as an exclusive approach, and SAHPRA reserves the right to request any additional information...

27 Mar Guideline for Liability Insurance for Clinical Trials

Posted at 14:53h in

This document has been prepared to serve as a guideline to clarify the requirements of insurance for those who conduct interventional clinical trials involving human participants and intend on making a submission for approval of a clinical trial by South African Health Products Regulatory Authority...

Archive

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

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

01 Apr E2B Standard as Acceptable Method of Reporting SAEs Occurring During Clinical Trial Conduct to SAHPRA

30 Mar Application Form: Rescheduling of a Substance or Medicine

30 Mar Guidelines to Clinical Trials in Pregnancy and Lactation

30 Mar Pre-clinical Testing Guidelines and Clinical Requirements for Phase I / First in Human (FIH) Studies

27 Mar Guideline for Liability Insurance for Clinical Trials

27 Mar Guideline for Remuneration of Volunteers in Phase 1 Clinical Trials

12 Jan Clinical Trial Insurance for New Clinical Trial Applications

05 Jan Electronic Submission of Serious Adverse Events (SAE) Reports – E2b Reporting

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