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Published on 21/12/2025

SAHPRA Submissions and EC Approvals Coordination SOP

Department	Clinical Research
SOP No.	CS/SAHPRA-SUB/185/2025
Supersedes	N.A.
Page No.	1 of 22
Issue Date	28/08/2025
Effective Date	05/09/2025
Review Date	05/09/2027

Purpose

The purpose of this SOP is to define standardized procedures for preparing and submitting clinical trial applications to the South African Health Products Regulatory Authority (SAHPRA) and coordinating with local Ethics Committees (ECs). It ensures compliance with South African regulations, Good Clinical Practice (GCP), and international standards for ethical trial conduct.

Scope

This SOP applies to all clinical trials conducted in South Africa that require approval from SAHPRA and local ECs. It includes submission of Clinical Trial Applications (CTAs), essential documents, safety reports, amendments, and coordination of dual approvals prior to site initiation. It applies to sponsors, CROs, investigators, and regulatory affairs teams.

Responsibilities

• Sponsor: Prepares the CTA and ensures both SAHPRA and EC approvals are obtained before trial initiation.
• Regulatory Affairs (RA): Manages dossier preparation, submission, and communication with SAHPRA and ECs.
• Principal Investigator (PI): Provides site-specific documents and ensures site initiation only after approvals.
• Clinical Project Manager (CPM): Tracks timelines, monitors submissions, and records approvals in TMF.
• Quality Assurance (QA): Audits submission packages and ensures readiness for SAHPRA inspections.

Accountability

The Sponsor’s Head of Regulatory Affairs is accountable for ensuring submissions to SAHPRA and ECs meet requirements. The PI is accountable for ensuring trial conduct does not commence without both approvals.

Procedure

1. Preparation of Clinical Trial Application (CTA)

1. Compile CTA package including protocol, Investigator’s Brochure, informed consent forms, investigational product information, GMP certificates, and insurance certificates.
2. Ensure dossier follows SAHPRA’s guidance on electronic submission format.
3. Maintain CTA Preparation Checklist in TMF (Annexure-1).

2. Submission to SAHPRA

1. Submit CTA electronically through SAHPRA Clinical Trials portal.
2. Record acknowledgement reference number and submission date in Submission Log.
3. Respond to SAHPRA queries within stipulated timelines.

3. Ethics Committee (EC) Submissions

1. Prepare ethics submission package including protocol, informed consent forms, recruitment materials, and PI CVs.
2. Submit package to EC simultaneously with SAHPRA submission.
3. Document EC approval letters and file in TMF and ISF.

4. Coordination of Approvals

1. Ensure no site initiations occur until both SAHPRA and EC approvals are obtained.
2. Record final approvals in Approval Tracker (Annexure-2).

5. Amendments

1. Classify amendments as substantial or administrative.
2. Submit substantial amendments to both SAHPRA and EC before implementation.
3. Maintain Amendment Log (Annexure-3).

6. Safety Reporting

1. Submit SUSARs, DSURs, and safety notifications to SAHPRA and EC per timelines.
2. Ensure acknowledgment receipts are filed.

7. Archiving

1. Archive submission packages, approval letters, and correspondence for 15 years or as per SAHPRA requirements.

Abbreviations

• SAHPRA: South African Health Products Regulatory Authority
• EC: Ethics Committee
• CTA: Clinical Trial Application
• PI: Principal Investigator
• RA: Regulatory Affairs
• QA: Quality Assurance
• CPM: Clinical Project Manager
• TMF: Trial Master File
• ISF: Investigator Site File

Documents

1. CTA Preparation Checklist (Annexure-1)
2. Approval Tracker (Annexure-2)
3. Amendment Log (Annexure-3)

References

• SAHPRA — Clinical Trials
• ICH E6(R2) Good Clinical Practice
• ICH Efficacy Guidelines

Version: 1.0

Approval

Prepared By	Checked By	Approved By
Name: Rajesh Kumar Date: 20/08/2025 Signature: __________	Name: Sunita Reddy Date: 22/08/2025 Signature: __________	Name: Dr. Meera Iyer Date: 28/08/2025 Signature: __________

Annexures

Annexure-1: CTA Preparation Checklist

Document	Included (Y/N)	Reviewer	Date
Protocol	Y	Rajesh Kumar	05/08/2025
Investigator’s Brochure	Y	Sunita Reddy	06/08/2025

Annexure-2: Approval Tracker

Authority	Protocol No.	Approval Ref	Approval Date	Status
SAHPRA	SA-2025-01	SAH-APP-001	15/09/2025	Approved
EC	SA-2025-01	EC-APP-005	10/09/2025	Approved

Annexure-3: Amendment Log

Date	Amendment	Submitted To	Status	Owner
20/10/2025	Amendment 1 — Updated Eligibility Criteria	SAHPRA & EC	Under Review	Neha Sharma

Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
28/08/2025	1.0	Initial SOP for SAHPRA submissions and EC coordination.	New SOP created for South African regulatory compliance.	Head of Clinical Research

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