| SAHPGL-RDN-INSP-01 | Guideline for the Sealing and Unsealing of Hazardous Substances | Guideline | 19/11/2024 | 2 | Inspectorate, Radiation Control | pdf | Download | guideline | inspectorate radiation-control |
| SAHPGL-CRO-02 | Guideline on Co-Applicancy | Guideline | 16/07/2024 | 1 | General ECTD & human medicines | pdf | Download | guideline | general-ectd-human-medicines-guidelines |
| SAHPGL-LIC-05 | GWP Guideline for the Importers and Distributors of Scheduled Substances | Guideline | 24/04/2024 | 1 | Licencing | pdf | Download | guideline | licencing |
| SAHPGL-RDN-XR-25 | Guidelines For Users of Electronic Therapeutic Devices Emitting Ionizing Radiation | Guideline | 13/12/2023 | 1 | Radiation Control, x-rays | pdf | Download | guideline | radiation-control x-rays |
| SAHPGL-RDN-XR-24 | Guideline for Import Applications of Electronic Devices Emitting Ionizing Radiation | Guideline | 13/12/2023 | 1 | Radiation Control, x-rays | pdf | Download | guideline | radiation-control x-rays |
| 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 |
| Medicines Online Directory Toolkit | Guide, Guideline, Presentations, Toolkit | 03/10/2023 | 1 | Corporate, General ECTD & human medicines | www | Download | guide guideline presentations toolkit | corporate general-ectd-human-medicines-guidelines |
| SAHPGL-PEM-VET-04 | General Information Guideline for Registration of Veterinary Medicines | Guideline | 27/06/2023 | 4 | Veterinary medicines | pdf | Download | guideline | veterinary-medicines |
| 2.24 | Guidance For The Submission Of The South African CTD-eCTD – General & Module | Guideline | 15/05/2019 | 6 | General ECTD & human medicines | | Download | guideline | general-ectd-human-medicines-guidelines |
| SAHPGL-PEM-04 | International Metric System (SI) | Guideline | 23/03/2023 | 4 | General ECTD & human medicines | pdf | Download | guideline | general-ectd-human-medicines-guidelines |
| SAHPGL-MD-07 | Guideline on Questions and Answers Licensing of Medical Device Establishments | FAQ, Guideline | 17/11/2023 | 3 | Medical Devices | pdf | Download | faq guideline | medical-devices |
| SAHPGL-CEM-PRE-01 | Guideline on Co-packaging of Medicines | Guideline | 15/02/2023 | 1 | CEM Pre-reg, Clinical Evaluations Management, General ECTD & human medicines | pdf | Download | guideline | cem-pre-reg clinical-evaluations-management general-ectd-human-medicines-guidelines |
| SAHPGL-CEM-PRE-02 | Guideline for Fixed Dose Combination Products (FDC Products) for HIVAIDS, Tuberculosis and Malaria | Guideline | 08/02/2023 | 2 | CEM Pre-reg, Clinical Evaluations Management, General ECTD & human medicines | pdf | Download | guideline | cem-pre-reg clinical-evaluations-management general-ectd-human-medicines-guidelines |
| 8.01 (Archived) | General Information Medical Devices And IVDs | Guideline | 13/08/2014 | 1 | Medical Devices | | Download | guideline | medical-devices |
| 8.06 (Archived) | Guideline For Access To And Control Of Medical Devices And IVDs | Guideline | 18/04/2017 | 1 | Medical Devices | | Download | guideline | medical-devices |
| SAHPGL-CEM-PV-03 | Risk Management Plans for Medicines for Human Use | Guideline | 15/09/2022 | 1 | Pharmacovigilance | pdf | Download | guideline | pharmacovigilance |
| SAHPGL-RDN-XR-17 | Guideline for Disposal of X-Ray Units and Tubes Containing Beryllium | Guideline | 17/08/2022 | 1 | Radiation Control, x-rays | pdf | Download | guideline | radiation-control x-rays |
| SAHPGL-RDN-XR-03 | Guideline for Dental Radiography | Guideline | 16/08/2022 | 1 | Radiation Control, x-rays | pdf | Download | guideline | radiation-control x-rays |
| SAHPGL-RDN-XR-23 | Guideline Radiologist Available by Remote Digital Connection | Guideline | 13/09/2022 | 1 | Radiation Control, x-rays | pdf | Download | guideline | radiation-control x-rays |
| SAHPGL-RDN-XR-09 | Guideline For Code Of Practice For Users Of Non – Medical X-RAY Equipment – Forensic | Guideline | 25/08/2022 | 1 | Radiation Control, x-rays | pdf | Download | guideline | radiation-control x-rays |
| SAHPGL-RDN-XR-16 | Guideline for Code of Practise for Industrial Radiography X-Ray | Guideline | 31/08/2022 | 1 | Radiation Control, x-rays | pdf | Download | guideline | radiation-control x-rays |
| SAHPGL-RDN-XR-07 | Guideline for Bone Densitometer – Operators | Guideline | 16/08/2022 | 1 | Radiation Control, x-rays | pdf | Download | guideline | radiation-control x-rays |
| SAHPGL-RDN-XR-12 | Guideline for Monitoring of Radiation workers in a Theatre | Guideline | 23/08/2022 | 1 | Radiation Control, x-rays | pdf | Download | guideline | radiation-control x-rays |
| SAHPGL-RDN-XR-04 | Guideline for Minimum Requirements For Fixed Diagnostic X-Ray Installations | Guideline | 17/08/2022 | 1 | Radiation Control, x-rays | pdf | Download | guideline | radiation-control x-rays |
| SAHPGL-RDN-XR-06 | Guideline For Reducing Radiation Risk From Computer Tomography For Pediatric And Small Adult Patients | Guideline | 17/08/2022 | 1 | Radiation Control, x-rays | pdf | Download | guideline | radiation-control x-rays |
| SAHPGL-RDN-XR-02 | Guideline For Code Of Practice For Users Of Medical Xray Equipment | Guideline | 17/08/2022 | 1 | Radiation Control, x-rays | pdf | Download | guideline | radiation-control x-rays |
| SAHPGL-RDN-XR-11 | General Guidelines with Regards to the Design of X-Ray Rooms | Guideline | 23/08/2022 | 1 | Radiation Control, x-rays | pdf | Download | guideline | radiation-control x-rays |
| SAHPGL-RDN-XR-05 | General Guideline For Cabinet And Conveyer Belt X-ray | Guideline | 17/08/2022 | 1 | Radiation Control, x-rays | pdf | Download | guideline | radiation-control x-rays |
| SAHPGL-RDN-XR-08 | Guideline for Personal Monitoring Med and Vet Use of Diagnostic X-Ray Equipment | Guideline | 24/08/2022 | 1 | Radiation Control, x-rays | pdf | Download | guideline | radiation-control x-rays |
| SAHPGL-RDN-XR-13 | Guideline for QC in Dental Diagnostic X-Ray Imaging Systems | Guideline | 31/08/2022 | 1 | Radiation Control, x-rays | pdf | Download | guideline | radiation-control x-rays |
| SAHPGL-RDN-XR-01 | Guideline for QC in Medical Diagnostic X-Ray Imaging Systems | Guideline | 16/08/2022 | 1 | Radiation Control, x-rays | pdf | Download | guideline | radiation-control x-rays |
| SAHPGL-RDN-XR-14 | Guideline of Test Procedures for Film Processing and Intensifying Screens | Guideline | 08/08/2022 | 1 | Radiation Control, x-rays | pdf | Download | guideline | radiation-control x-rays |
| SAHPGL-RDN-XR-18 | Guidelines on Requests for Medical X-Ray Examinations | Guideline | 20/09/2022 | 1 | Radiation Control, x-rays | pdf | Download | guideline | radiation-control x-rays |
| SAHPGL-RDN-XR-10 | Guideline For Radiation Monitoring Requirements And Radiation Occurrences | Guideline | 03/08/2022 | 1 | Radiation Control, x-rays | pdf | Download | guideline | radiation-control x-rays |
| SAHPGL-RDN-XR-20 | Guideline for Use of Radiographic Grid Ratio | Guideline | 20/09/2022 | 1 | Radiation Control, x-rays | pdf | Download | guideline | radiation-control x-rays |
| SAHPGL-RDN-XR-22 | Guideline for Protective Clothing | Guideline | 20/09/2022 | 1 | Radiation Control, x-rays | pdf | Download | guideline | radiation-control x-rays |
| SAHPGL-RDN-XR-21 | Guideline for Patient Dose Measurements in Diagnostic Radiology | Guideline | 21/09/2022 | 1 | Radiation Control, x-rays | pdf | Download | guideline | radiation-control x-rays |
| SAHPGL-RDN-RN-13 | Management and Disposal of Non-nuclear Radioactive Waste | Guideline | 05/12/2022 | 2 | Radiation Control, Radionuclides | pdf | Download | guideline | radiation-control radionuclides |
| SAHPGL-RDN-RN-06 (Old UNSEAL) | Guideline For Safe Use of Unsealed Radioactive Nuclides | Guideline | 01/02/2024 | 1 | Radiation Control, Radionuclides | pdf | Download | guideline | radiation-control radionuclides |
| SAHPGL-RDN-RN-14 (Old TRUG91-1) | Guideline For The Safe Transport of Radioactive Material | Guideline | 20/02/2024 | 2 | Radiation Control, Radionuclides | pdf | Download | guideline | radiation-control radionuclides |
| SAHPGL-RDN-RN-15 | Identification and Labelling of Radioactive Sources and Source Containers | Guideline | 08/02/2024 | 2 | Radiation Control, Radionuclides | pdf | Download | guideline | radiation-control radionuclides |
| SAHPGL-RDN-RN-09 | I-131 Therapy | Guideline | 12/12/2022 | 2 | Radiation Control, Radionuclides | pdf | Download | guideline | radiation-control radionuclides |
| SAHPGL-RDN-RN-12 | Reporting National Radiation Occurrences | Guideline | 05/12/2022 | 2 | Radiation Control, Radionuclides | pdf | Download | guideline | radiation-control radionuclides |
| SAHPGL-RDN-RN-04 (Old IRCP91-2) | Guideline for Industrial Radiography | Guideline | 18/06/2024 | 2 | Radiation Control, Radionuclides | pdf | Download | guideline | radiation-control radionuclides |
| SAHPGL-RDN-RN-08 (Old GAUGE) | Guideline For The Safe Use of Industrial Gauges Containing Radioactive Sources | Guideline | 01/02/2024 | 2 | Radiation Control, Radionuclides | pdf | Download | guideline | radiation-control radionuclides |
| SAHPGL-RDN-RN-01 (Old FIRE) | Guideline on Protective Measures To Take In The Event of an Accident Involving Radioactivity | Guideline | 01/02/2024 | 2 | Radiation Control, Radionuclides | pdf | Download | guideline | radiation-control radionuclides |
| SAHPGL-RDN-XR-15 | Guideline for Ionising Radiation Dose Limits and Annual Limits on Intake of Radioactive Material | Guideline | 23/08/2022 | 1 | Radiation Control, Radionuclides, x-rays | pdf | Download | guideline | radiation-control radionuclides x-rays |
| SAHPGL-RDN-RN-03 | Guideline on The Safe Use of Soil Moisture and Density Gauges Containing Radioactive Sources | Guideline | 01/02/2024 | 2 | Radiation Control, Radionuclides | pdf | Download | guideline | radiation-control radionuclides |
| SAHPGL-RDN-RN-02 | Guideline On The Organisational Requirements For Authority Holders And Their Appointed Radiation Protection Officers | Guideline | 01/02/2024 | 2 | Radiation Control, Radionuclides | pdf | Download | guideline | radiation-control radionuclides |
| SAHPGL-RDN-RN-11 | RPO Competence and Training Requirements | Guideline | 05/12/2022 | 2 | Radiation Control, Radionuclides | pdf | Download | guideline | radiation-control radionuclides |
| SAHPGL-RDN-RN-10 | Leak tests | Guideline | 05/12/2022 | 3 | Radiation Control, Radionuclides | pdf | Download | guideline | radiation-control radionuclides |
| SAHGPL-RDN-XR-19 | Guideline for Management of Pregnant Radiographers and Other Staff Members | Guideline | 07/09/2022 | 1 | Radiation Control, Radionuclides, x-rays | pdf | Download | guideline | radiation-control radionuclides x-rays |
| SAHPGL-RDN-RN-17 | Guideline on Requests for Medical Examinations for Radiation Workers | Guideline | 20/02/2024 | 2 | Radiation Control, Radionuclides | pdf | Download | guideline | radiation-control radionuclides |
| 2.21 | South African Specification for eCTD Regional Module1 | Guideline | 11/03/2024 | 3.1 | General ECTD & human medicines | pdf | Download | guideline | general-ectd-human-medicines-guidelines |
| SAHPGL-RDN-RN-05 | Guideline On Afterloader Source Exchange Forms (RNXM) | Guideline | 20/07/2022 | 1 | Radiation Control, Radionuclides | pdf | Download | guideline | radiation-control radionuclides |
| SAHPGL-INSP-RC-13 | Guideline For Cultivation Of Cannabis | Guideline | 10/11/2022 | 3 | Cannabis, Licencing, Regulatory Compliance | pdf | Download | guideline | cannabis licencing regulatory-compliance |
| SAHPGL-PEM-VET-01 | Guideline on application for use of unregistered veterinary medicines | Guideline | 22/03/2024 | 3 | Emergency use, Section 21, Unregistered products, Veterinary medicines | pdf | Download | guideline | emergency-use section-21 unregistered-products veterinary-medicines |
| 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-LIC-03 | Guideline on How to Amend a Current Licence | Guideline | 22/06/2022 | 1 | Licencing | pdf | Download | guideline | licencing |
| SAHPGL-LIC-02 | Guideline on How to Apply for A Licence to Act as A Wholesaler | Guideline | 22/06/2022 | 2 | Licencing | pdf | Download | guideline | licencing |
| SAHPGL-HPA-04 | Renewal of Human and Veterinary Medicines Requirements and Process | Guideline | 09/09/2024 | 5 | General ECTD & human medicines, HPA, Veterinary medicines | pdf | Download | guideline | general-ectd-human-medicines-guidelines hpa veterinary-medicines |
| SAHPGL-INSP-RC-01 | Guidelines for Post Marketing Surveillance of Medicines and Health Products | Guideline | 27/07/2023 | 3 | Regulatory Compliance | pdf | Download | guideline | regulatory-compliance |
| SAHPGL-INSP-RC-11 | Guideline for Release of Import Health Products at Ports of Entry | Guideline | 08/06/2022 | 2 | Regulatory Compliance | pdf | Download | guideline | regulatory-compliance |
| SAHPGL-INSP-RC-07 | Guidelines for Advertisement of Medicines and Health Products | Guideline | 23/06/2022 | 2 | Regulatory Compliance | pdf | Download | guideline | regulatory-compliance |
| SAHPGL-INSP-RC-06 | Guideline to Fee Determination and Payments of Permits and Related Authorisations | Guideline | 14/06/2022 | 1 | Regulatory Compliance | pdf | Download | guideline | regulatory-compliance |
| SAHPGL-INSP-RC-05 | Guidelines for Medicine Recalls – Withdrawals and Rapid Alerts | Guideline | 15/02/2024 | 4 | Regulatory Compliance | pdf | Download | guideline | regulatory-compliance |
| SAHPGL-CEM-PV-04 | Post-marketing Reporting Of Adverse Drug Reactions To Human Medicines In South Africa | Guideline | 08/06/2022 | 9 | Pharmacovigilance | pdf | Download | guideline | pharmacovigilance |
| SAHPGL-PEM-BIO-01 | Guideline for Lot Release of Human Vaccines | Guideline | 08/06/2023 | 4 | Biological Medicines | pdf | Download | guideline | biological-medicines-evaluation-and-research |
| SAHPGL-CEM-NS-01 | Application for rescheduling of a substance or medicine | Guideline | 12/05/2022 | 1 | Names and Scheduling | pdf | Download | guideline | names-and-scheduling |
| SAHPGL-CEM-PV-02 | Pharmacovigilance systems | Guideline | 06/06/2023 | 2 | Pharmacovigilance | pdf | Download | guideline | pharmacovigilance |
| SAHPGL-CEM-PV-01 | Pharmacovigilance Inspections for Human Medicinal Products | Guideline | 10/05/2022 | 1 | Pharmacovigilance | pdf | Download | guideline | pharmacovigilance |
| SAHPGL-GOV-01 | Guideline for appeals against Regulatory decisions | Guideline | 13/04/2022 | 1 | Quality Management System | pdf | Download | guideline | quality-management-system |
| SAHPGL-PEM-BIO-06 | General guidance document on QSE for Biological Medicines | Guideline | 24/08/2022 | 2 | Biological Medicines | pdf | Download | guideline | biological-medicines-evaluation-and-research |
| SAHPGL-HPA-08 | Multiple Applications Guideline | Guideline | 11/12/2023 | 3 | General ECTD & human medicines, HPA | pdf | Download | guideline | general-ectd-human-medicines-guidelines hpa |
| SAHPGL-PEM-VET-02 | Veterinary Medicines Clinical Guideline | Guideline | 13/09/2022 | 2 | Quality, Veterinary medicines | pdf | Download | guideline | quality veterinary-medicines |
| SAHPGL-PEM-VET-03 | Veterinary Medicines Exemptions from certain Medicine Registration Requirements | Guideline | 26/06/2023 | 2 | Quality, Veterinary medicines | pdf | Download | guideline | quality veterinary-medicines |
| SAHPGL-FIN-01 | SAHPRA Payment Guideline | Guideline | 12/02/2024 | 8 | Finance | pdf | Download | guideline | finance |
| 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 |
| SAHPGL-CEM-PV-05 | Guideline for the handling of Dear Healthcare Professional Letters relating to medicine safety | Guideline | 25/08/2022 | 6 | Pharmacovigilance | pdf | Download | guideline | pharmacovigilance |
| SAHPGL-CEM-PV-06 | Guideline For Adverse Drug Reactions (ADRs) Reporting for Healthcare Professionals | Guideline | 18/08/2022 | 3 | Pharmacovigilance | pdf | Download | guideline | pharmacovigilance |
| SAHPGL-INSP-RC-12 | Guideline On How To Lodge A Complaint On Medicines And Medical Devices | Guideline | 10/11/2022 | 4 | Regulatory Compliance | pdf | Download | guideline | regulatory-compliance |
| SAHPGL-INSP-RC-02 | Guideline for the Importation and Exportation of Medicines | Guideline | 08/06/2022 | 2 | Regulatory Compliance | pdf | Download | guideline | regulatory-compliance |
| SAHPGL-LIC-01 | Licence to Manufacture, Import or Export | Guideline | 09/06/2022 | 3 | Licencing | pdf | Download | guideline | licencing |
| SAHPGL-INSP-06 | Guideline for Fee determination and Payment of GxP and Product related Inspection | Guideline | 14/09/2022 | 2 | Inspectorate and good manufacturing practices | pdf | Download | guideline | inspectorate-and-good-manufacturing-practices |
| SAHPGL-INSP-05 | Guideline on how to respond to a GMP, GWP, GCP and GVP Inspection report | Guideline | 21/09/2022 | 2 | Inspectorate and good manufacturing practices | pdf | Download | guideline | inspectorate-and-good-manufacturing-practices |
| SAHPGL-INSP-04 | Guideline for preparation of site master file | Guideline | 14/09/2022 | 5 | Inspectorate and good manufacturing practices, Licencing | pdf | Download | guideline | inspectorate-and-good-manufacturing-practices licencing |
| SAHPGL-INSP-03 | Guideline for Good Wholesaling Practice for Wholesaler | Guideline | 07/09/2022 | 5 | Inspectorate and good manufacturing practices, Licencing | pdf | Download | guideline | inspectorate-and-good-manufacturing-practices licencing |
| SAHPGL-INSP-01 | Guideline for Post Importation Testing | Guideline | 15/09/2022 | 5 | Inspectorate and good manufacturing practices | pdf | Download | guideline | inspectorate-and-good-manufacturing-practices |
| SAHPGL-CEM-S21-02 | Guideline For Section 21 Access To Unregistered Medicines | Guideline | 05/08/2022 | 4 | Emergency use, Section 21, Unregistered products | pdf | Download | guideline | emergency-use section-21 unregistered-products |
| Section 21 Access to Unregistered Medicines – IVERMECTIN CONTROLLED COMPASSIONATE USE PROGRAMME | Communication to industry, Guideline | 19/05/2022 | 2 | Emergency use, Section 21, Unregistered products | www | Download | communication-to-industry guideline | emergency-use section-21 unregistered-products |
