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About us
Who we are
Board
Executive Management
Expressions of Interest
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eCTD Submissions Portal
Quality Management System
Regulatory Partnerships
Agreements/MOUs
Special Projects
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Application portal
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Templates
Clinical Trials
Communication To Industry
FAQs
Forms
Guidelines
Inspectorate and Regulatory Compliance
Importation – Border Control
Medical Devices
Communication to Industry
Forms
Guidelines
Conformity assessment bodies
Licenced Establishments
Position Statements
Related Documents
Test Kits
Names and Scheduling
Amended Schedules
Consolidated Schedules
Guidelines
Orthodox Medicines
Communication to Industry
Forms
Guidelines
Registered Health Products
Templates
Radiation Control
Communication To Industry
Acts and Regulations
Forms
Templates
Guidelines & Codes of Practice
Inspection bodies
News & Updates
Safety Information
Pharmacovigilance
Covid-19 Adverse Events Report
Health Product Vigilance
Product Recalls
Rapid Alerts
Recalls Reporting
Report Side Effects
Safety Alerts
Unregistered Products/Section 21
Category A Medicines
Complementary Medicines
Medical Devices
Veterinary Medicines
Veterinary Medicines
Forms
Guidelines
Registered Vet Products
Veterinary Portal
Databases & Registers
Medical Devices Licences Issued
OTC Medicines Directory
OTC Toolkit
Pharma Licenced Establishments
Revoked or Suspended Pharma Licences
PI & PIL Repository
Registered Health Products
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E-Services
Adverse Drug Reaction Reporting
AEFI Reporting Dashboard
Complementary Medicines Licensing
COVI-VIG Reporting System
eCTD Submissions Portal
Health Product Application Status Checker
Health Products Variations Status Checker
Lot Release Search
Med Safety App
Mpox Monitoring
OTC Medicines Directory
OTC Toolkit
Product Variations Portal
Registered Health Products
Section 21 Applications
VET Status Checker
VET Variation Status Checker
E-Library
Acts, Regulations & Policies
Acts
Govt Gazettes And Regulations
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Corporate & Publications
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Clinical Trials Guidelines
Document Number
Title
Categories
Date Updated
Version
Units
File Type
Link
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Clinical Trials Committee and Submission Dates for 2024
Communication to industry
,
Guideline
12/10/2023
1
Clinical Evaluations Management
,
Clinical Trials
pdf
Download
communication-to-industry guideline
clinical-evaluations-management clinical-trials
Guideline on completion of the veterinary medicines clinical trial application form
Guideline
19/09/2019
1
Clinical Evaluations Management
,
Clinical Trials
,
Quality
,
Veterinary medicines
Download
guideline
clinical-evaluations-management clinical-trials quality veterinary-medicines
SAHPGL-CEM-CT-09
Guideline for Clinical Trial Investigators
Guideline
24/10/2022
3
Clinical Evaluations Management
,
Clinical Trials
pdf
Download
guideline
clinical-evaluations-management clinical-trials
SAHPGL-CEM-CT-01
Guideline For Electronic Submission of Clinical Trial Documents (Amendments, Bioequivalence Studies, Responses, Notifications, And Serious Adverse Events)
Guideline
05/09/2022
3
Clinical Evaluations Management
,
Clinical Trials
pdf
Download
guideline
clinical-evaluations-management clinical-trials
SAHPGL-CEM-CT-06
Procedure for Consultation Meetings with Clinical Trial Applicants
Guideline
11/08/2022
2
Clinical Evaluations Management
,
Clinical Trials
pdf
Download
guideline
clinical-evaluations-management clinical-trials
SAHPGL-CEM-CT-05
Liability Insurance for Clinical Trials
Guideline
17/08/2022
3
Clinical Evaluations Management
,
Clinical Trials
pdf
Download
guideline
clinical-evaluations-management clinical-trials
SAHPGL-CEM-CT-02
Clinical Trial Participant Time, Inconvenience and Expense (TIE) Compensation Model
Guideline
01/07/2022
2
Clinical Evaluations Management
,
Clinical Trials
pdf
Download
guideline
clinical-evaluations-management clinical-trials
SAHPGL-CEM-CT-08
Guideline for Capacity Building and Transformation in Clinical Research in South Africa
Guideline
01/10/2022
2
Clinical Evaluations Management
,
Clinical Trials
pdf
Download
guideline
clinical-evaluations-management clinical-trials
SAHPGL-CEM-CT-04
Oversight and Monitoring in Clinical Trials
Guideline
01/08/2022
4
Clinical Evaluations Management
,
Clinical Trials
pdf
Download
guideline
clinical-evaluations-management clinical-trials
SAHPGL-CEM-CT-07
Post Clinical Trial Access
Guideline
03/08/2022
4
Clinical Evaluations Management
,
Clinical Trials
pdf
Download
guideline
clinical-evaluations-management clinical-trials
SAHPGL-CEM-CT-03
Emergency Procedures for Clinical Trial Sites
Guideline
17/08/2022
3
Clinical Evaluations Management
,
Clinical Trials
pdf
Download
guideline
clinical-evaluations-management clinical-trials
SAHPGL-CEM-CT-10
Safety Reporting During Clinical Trials
Guideline
06/10/2022
5
Clinical Evaluations Management
,
Clinical Trials
pdf
Download
guideline
clinical-evaluations-management clinical-trials
SA Good Clinical Practice Guidelines
Guideline
17/06/2020
3
Clinical Evaluations Management
,
Clinical Trials
pdf
Download
guideline
clinical-evaluations-management clinical-trials
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