Covid-19 | Subscribe

Guidelines

In our commitment to ensuring that all registered medicines will be of the required quality, safety, and efficacy, the South African Health Products Regulatory Authority (SAHPRA) aligns its guidelines to the frameworks of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH).

  • In the second drop-down, choose the relevant unit.
    • You can also choose one option at a time and search results will appear.
  • When you have multiple searches, make sure to always click the “reset” button.
  • Or you can simply use the general “Search” area to the right-hand side of this page.
Document NumberTitleCategoriesDate UpdatedVersionUnitsFile TypeLinkdoc_categories_hfilterdoc_tags_hfilter
SAHPGL-HPA-09SAHPRA ECTD Specification 3.1 and Guidance for Module 1 and Regional Information09/10/20254, pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines hpa
SAHPGL-INSP-RC-04Guideline on Traceability of Health Products01/10/20251pdfDownloadguidelineregulatory-compliance
SAHPGL-MD-18Post Market Surveillance and Post-market Clinical Follow-up Studies09/09/20251pdfDownloadguidelinemedical-devices
SAHPGL-MD-16Guidelines on Clinical Evaluation of Medical Devices09/09/20251pdfDownloadguidelinemedical-devices
SAHPGL-MD-17Guideline on Clinical Investigation of Medical Devices09/09/20251pdfDownloadguidelinemedical-devices
SAHPGL-RDN-XR-26Approval of a dosimetry service in South Africa31/01/20252, pdfDownloadguidelineradiation-control x-rays
8.04 (Archived)Recalls Vigilance Medical Devices IVDs14/11/20192Downloadguidelinemedical-devices
GLF-MD-11AMedical Device Adverse Event Reporting Form13/12/20241docxDownloadguidelinemedical-devices
SAHPGL-MD-11Guideline for Completing Medical Device Adverse Event Form for Licensed Holders (Licensee) / Holders of a Certificate Of Registration of al Medical Device (including an IVD)13/12/20241pdfDownloadguidelinemedical-devices
SAHPGL-RDN-INSP-01Guideline for the Sealing and Unsealing of Hazardous Substances19/11/20242, pdfDownloadguidelineinspectorate radiation-control
SAHPGL-CRO-02Guideline on Co-Applicancy16/07/20241pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines
SAHPGL-LIC-05GWP Guideline for the Importers and Distributors of Scheduled Substances24/04/20241pdfDownloadguidelinelicencing
SAHPGL-RDN-XR-25Guidelines For Users of Electronic Therapeutic Devices Emitting Ionizing Radiation16/01/20241, pdfDownloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-24Guideline for Import Applications of Electronic Devices Emitting Ionizing Radiation13/12/20231, pdfDownloadguidelineradiation-control x-rays
Clinical Trials Committee and Submission Dates for 2024, 12/10/20231, pdfDownloadcommunication-to-industry guidelineclinical-evaluations-management clinical-trials
Medicines Online Directory Toolkit, , , 03/10/20231, wwwDownloadguide guideline presentations toolkitcorporate general-ectd-human-medicines-guidelines
SAHPGL-PEM-VET-04General Information Guideline for Registration of Veterinary Medicines27/06/20234pdfDownloadguidelineveterinary-medicines
2.24Guidance For The Submission Of The South African CTD-eCTD – General & Module15/05/20196Downloadguidelinegeneral-ectd-human-medicines-guidelines
SAHPGL-PEM-04International Metric System (SI)23/03/20234pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines
SAHPGL-MD-07Guideline on Questions and Answers Licensing of Medical Device Establishments, 21/05/20254pdfDownloadfaq guidelinemedical-devices
SAHPGL-CEM-PRE-01Guideline on Co-packaging of Medicines15/02/20231, , pdfDownloadguidelinecem-pre-reg clinical-evaluations-management general-ectd-human-medicines-guidelines
SAHPGL-CEM-PRE-02Guideline for Fixed Dose Combination Products (FDC Products) for HIVAIDS, Tuberculosis and Malaria08/02/20232, , pdfDownloadguidelinecem-pre-reg clinical-evaluations-management general-ectd-human-medicines-guidelines
8.01 (Archived)General Information Medical Devices And IVDs13/08/20141Downloadguidelinemedical-devices
8.06 (Archived)Guideline For Access To And Control Of Medical Devices And IVDs18/04/20171Downloadguidelinemedical-devices
SAHPGL-CEM-PV-03Risk Management Plans for Medicines for Human Use15/09/20221pdfDownloadguidelinepharmacovigilance
SAHPGL-RDN-XR-17Guideline for Disposal of X-Ray Units and Tubes Containing Beryllium17/08/20221, pdfDownloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-03Guideline for Dental Radiography16/08/20221, pdfDownloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-23Guideline Radiologist Available by Remote Digital Connection13/09/20221, pdfDownloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-09Guideline For Code Of Practice For Users Of Non – Medical X-RAY Equipment – Forensic25/08/20221, pdfDownloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-16Guideline for Code of Practise for Industrial Radiography X-Ray31/08/20221, pdfDownloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-07Guideline for Bone Densitometer – Operators16/08/20221, pdfDownloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-12Guideline for Monitoring of Radiation workers in a Theatre23/08/20221, pdfDownloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-04Guideline for Minimum Requirements For Fixed Diagnostic X-Ray Installations17/08/20221, pdfDownloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-06Guideline For Reducing Radiation Risk From Computer Tomography For Pediatric And Small Adult Patients17/08/20221, pdfDownloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-02Guideline For Code Of Practice For Users Of Medical Xray Equipment17/08/20221, pdfDownloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-11General Guidelines with Regards to the Design of X-Ray Rooms23/08/20221, pdfDownloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-05General Guideline For Cabinet And Conveyer Belt X-ray17/08/20221, pdfDownloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-08Guideline for Personal Monitoring Med and Vet Use of Diagnostic X-Ray Equipment24/08/20221, pdfDownloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-13Guideline for QC in Dental Diagnostic X-Ray Imaging Systems31/08/20221, pdfDownloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-01Guideline for QC in Medical Diagnostic X-Ray Imaging Systems16/08/20221, pdfDownloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-14Guideline of Test Procedures for Film Processing and Intensifying Screens08/08/20221, pdfDownloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-18Guidelines on Requests for Medical X-Ray Examinations20/09/20221, pdfDownloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-10Guideline For Radiation Monitoring Requirements And Radiation Occurrences03/08/20221, pdfDownloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-20Guideline for Use of Radiographic Grid Ratio20/09/20221, pdfDownloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-22Guideline for Protective Clothing20/09/20221, pdfDownloadguidelineradiation-control x-rays
SAHPGL-RDN-XR-21Guideline for Patient Dose Measurements in Diagnostic Radiology21/09/20221, pdfDownloadguidelineradiation-control x-rays
SAHPGL-RDN-RN-13Management and Disposal of Non-nuclear Radioactive Waste05/12/20222, pdfDownloadguidelineradiation-control radionuclides
SAHPGL-RDN-RN-06 (Old UNSEAL)Guideline For Safe Use of Unsealed Radioactive Nuclides01/02/20241, pdfDownloadguidelineradiation-control radionuclides
SAHPGL-RDN-RN-14 (Old TRUG91-1)Guideline For The Safe Transport of Radioactive Material20/02/20242, pdfDownloadguidelineradiation-control radionuclides
SAHPGL-RDN-RN-15Identification and Labelling of Radioactive Sources and Source Containers08/02/20242, pdfDownloadguidelineradiation-control radionuclides
SAHPGL-RDN-RN-09I-131 Therapy12/12/20222, pdfDownloadguidelineradiation-control radionuclides
SAHPGL-RDN-RN-12Reporting National Radiation Occurrences05/12/20222, pdfDownloadguidelineradiation-control radionuclides
SAHPGL-RDN-RN-04 (Old IRCP91-2)Guideline for Industrial Radiography18/06/20242, pdfDownloadguidelineradiation-control radionuclides
SAHPGL-RDN-RN-08 (Old GAUGE)Guideline For The Safe Use of Industrial Gauges Containing Radioactive Sources01/02/20242, pdfDownloadguidelineradiation-control radionuclides
SAHPGL-RDN-RN-01 (Old FIRE)Guideline on Protective Measures To Take In The Event of an Accident Involving Radioactivity01/02/20242, pdfDownloadguidelineradiation-control radionuclides
SAHPGL-RDN-XR-15Guideline for Ionising Radiation Dose Limits and Annual Limits on Intake of Radioactive Material23/08/20221, , pdfDownloadguidelineradiation-control radionuclides x-rays
SAHPGL-RDN-RN-03Guideline on The Safe Use of Soil Moisture and Density Gauges Containing Radioactive Sources01/02/20242, pdfDownloadguidelineradiation-control radionuclides
SAHPGL-RDN-RN-02Guideline On The Organisational Requirements For Authority Holders And Their Appointed Radiation Protection Officers01/02/20242, pdfDownloadguidelineradiation-control radionuclides
SAHPGL-RDN-RN-11RPO Competence and Training Requirements05/12/20222, pdfDownloadguidelineradiation-control radionuclides
SAHPGL-RDN-RN-10Leak tests05/12/20223, pdfDownloadguidelineradiation-control radionuclides
SAHGPL-RDN-XR-19Guideline for Management of Pregnant Radiographers and Other Staff Members07/09/20221, , pdfDownloadguidelineradiation-control radionuclides x-rays
SAHPGL-RDN-RN-17Guideline on Requests for Medical Examinations for Radiation Workers20/02/20242, pdfDownloadguidelineradiation-control radionuclides
SAHPGL-RDN-RN-05Guideline On Afterloader Source Exchange Forms (RNXM)20/07/20221, pdfDownloadguidelineradiation-control radionuclides
SAHPGL-INSP-RC-13Guideline For Cultivation Of Cannabis10/11/20223, , pdfDownloadguidelinecannabis licencing regulatory-compliance
SAHPGL-PEM-VET-01Guideline on application for use of unregistered veterinary medicines22/03/20243, , , pdfDownloadguidelineemergency-use section-21 unregistered-products veterinary-medicines
Guideline on completion of the veterinary medicines clinical trial application form19/09/20191, , , Downloadguidelineclinical-evaluations-management clinical-trials quality veterinary-medicines
SAHPGL-LIC-03Guideline on How to Amend a Current Licence22/06/20221pdfDownloadguidelinelicencing
SAHPGL-LIC-02Guideline on How to Apply for A Licence to Act as A Wholesaler22/06/20222pdfDownloadguidelinelicencing
SAHPGL-HPA-04Renewal of Human and Veterinary Medicines Requirements and Process12/02/20256, , pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines hpa veterinary-medicines
SAHPGL-INSP-RC-01Guidelines for Post Marketing Surveillance of Medicines and Health Products27/07/20233pdfDownloadguidelineregulatory-compliance
SAHPGL-INSP-RC-11Guideline for Release of Import Health Products at Ports of Entry08/06/20222pdfDownloadguidelineregulatory-compliance
SAHPGL-INSP-RC-07Guidelines for Advertisement of Medicines and Health Products23/06/20222pdfDownloadguidelineregulatory-compliance
SAHPGL-INSP-RC-06 Guideline to Fee Determination and Payments of Permits and Related Authorisations14/06/20221pdfDownloadguidelineregulatory-compliance
SAHPGL-INSP-RC-05Guidelines for Medicine Recalls – Withdrawals and Rapid Alerts15/02/20244pdfDownloadguidelineregulatory-compliance
SAHPGL-CEM-PV-04Post-marketing Reporting of Adverse Drug Reactions for Human Medicines in South Africa22/09/202510pdfDownloadguidelinepharmacovigilance
SAHPGL-PEM-BIO-01Guideline for Lot Release of Human Vaccines08/06/20234pdfDownloadguidelinebiological-medicines-evaluation-and-research
SAHPGL-CEM-NS-01Application for rescheduling of a substance or medicine12/05/20221pdfDownloadguidelinenames-and-scheduling
SAHPGL-CEM-PV-02Pharmacovigilance systems06/06/20232pdfDownloadguidelinepharmacovigilance
SAHPGL-CEM-PV-01Pharmacovigilance Inspections for Human Medicinal Products10/05/20221pdfDownloadguidelinepharmacovigilance
SAHPGL-LEG-01Guideline for Appeals Against Regulatory Decisions31/10/20243pdfDownloadguidelinelegal
SAHPGL-PEM-BIO-06General guidance document on QSE for Biological Medicines24/08/20222pdfDownloadguidelinebiological-medicines-evaluation-and-research
SAHPGL-HPA-08Multiple Applications Guideline11/12/20233, pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines hpa
SAHPGL-PEM-VET-02Veterinary Medicines Clinical Guideline13/09/20222, pdfDownloadguidelinequality veterinary-medicines
SAHPGL-PEM-VET-03Veterinary Medicines Exemptions from certain Medicine Registration Requirements26/06/20232, pdfDownloadguidelinequality veterinary-medicines
SAHPGL-FIN-01SAHPRA Payment Guideline12/02/20259pdfDownloadguidelinefinance
SAHPGL-CEM-CT-09Guideline for Clinical Trial Investigators24/10/20223, pdfDownloadguidelineclinical-evaluations-management clinical-trials
SAHPGL-CEM-CT-01Guideline For Electronic Submission of Clinical Trial Documents (Amendments, Bioequivalence Studies, Responses, Notifications, And Serious Adverse Events)05/09/20223, pdfDownloadguidelineclinical-evaluations-management clinical-trials
SAHPGL-CEM-CT-06Procedure for Consultation Meetings with Clinical Trial Applicants11/08/20222, pdfDownloadguidelineclinical-evaluations-management clinical-trials
SAHPGL-CEM-CT-05Liability Insurance for Clinical Trials17/08/20223, pdfDownloadguidelineclinical-evaluations-management clinical-trials
SAHPGL-CEM-CT-02Clinical Trial Participant Time, Inconvenience and Expense (TIE) Compensation Model01/07/20222, pdfDownloadguidelineclinical-evaluations-management clinical-trials
SAHPGL-CEM-CT-08Guideline for Capacity Building and Transformation in Clinical Research in South Africa01/10/20222, pdfDownloadguidelineclinical-evaluations-management clinical-trials
SAHPGL-CEM-CT-04Oversight and Monitoring in Clinical Trials01/08/20224, pdfDownloadguidelineclinical-evaluations-management clinical-trials
SAHPGL-CEM-CT-07Post Clinical Trial Access03/08/20224, pdfDownloadguidelineclinical-evaluations-management clinical-trials
SAHPGL-CEM-CT-03Emergency Procedures for Clinical Trial Sites17/08/20223, pdfDownloadguidelineclinical-evaluations-management clinical-trials
SAHPGL-CEM-CT-10Safety Reporting During Clinical Trials06/10/20225, pdfDownloadguidelineclinical-evaluations-management clinical-trials
SA Good Clinical Practice Guidelines17/06/20203, pdfDownloadguidelineclinical-evaluations-management clinical-trials
SAHPGL-CEM-PV-05Guideline for the handling of Dear Healthcare Professional Letters relating to medicine safety25/08/20226pdfDownloadguidelinepharmacovigilance
SAHPGL-CEM-PV-06Guideline For Adverse Drug Reactions (ADRs) Reporting for Healthcare Professionals18/08/20223pdfDownloadguidelinepharmacovigilance
SAHPGL-INSP-RC-12Guideline On How To Lodge A Complaint On Medicines And Medical Devices10/11/20224pdfDownloadguidelineregulatory-compliance
SAHPGL-INSP-RC-02Guideline for the Importation and Exportation of Medicines08/06/20222pdfDownloadguidelineregulatory-compliance
SAHPGL-LIC-01Licence to Manufacture, Import or Export09/06/20223pdfDownloadguidelinelicencing
SAHPGL-INSP-06Guideline for Fee determination and Payment of GxP and Product related Inspection14/09/20222pdfDownloadguidelineinspectorate-and-good-manufacturing-practices
SAHPGL-INSP-05Guideline on how to respond to a GMP, GWP, GCP and GVP Inspection report21/09/20222pdfDownloadguidelineinspectorate-and-good-manufacturing-practices
SAHPGL-INSP-04Guideline for preparation of site master file14/09/20225, pdfDownloadguidelineinspectorate-and-good-manufacturing-practices licencing
SAHPGL-INSP-03Guideline for Good Wholesaling Practice for Wholesaler07/09/20225, pdfDownloadguidelineinspectorate-and-good-manufacturing-practices licencing
SAHPGL-INSP-01Guideline for Post Importation Testing15/09/20225pdfDownloadguidelineinspectorate-and-good-manufacturing-practices
SAHPGL-CEM-S21-02Guideline For Section 21 Access To Unregistered Medicines22/09/20255, , pdfDownloadguidelineemergency-use section-21 unregistered-products
Section 21 Access to Unregistered Medicines – IVERMECTIN CONTROLLED COMPASSIONATE USE PROGRAMME, 19/05/20222, , wwwDownloadcommunication-to-industry guidelineemergency-use section-21 unregistered-products
SAHPGL-MD-06Guideline for a License to Manufacture, Import, Export, or Distribute Medical Devices and IVDs23/03/20233pdfDownloadguidelinemedical-devices
SAHPGL-MD-05Guideline on Medical Device Quality Manual14/03/20234pdfDownloadguidelinemedical-devices
SAHPGL-MD-04 Guideline for Classification of Medical Devices and IVDs28/02/20255pdfDownloadguidelinemedical-devices
SAHPGL-MD-03 (previously 8.04)Guideline for Medical Device Adverse Event Reporting13/12/20244pdfDownloadguidelinemedical-devices
7.06CMs Specified Substances12/01/20223pdfDownloadguidelinecomplementary-medicines
7.05Complementary Medicines Registration Application ZA-CTD-Quality25/06/20202pdfDownloadguidelinecomplementary-medicines
7.04Complementary Medicines – Health Supplements Safety and Efficacy09/03/20224pdfDownloadguidelinecomplementary-medicines
7.03Complementary Medicines – Use of the ZA-CTD format in the preparation of registration applications25/06/20203pdfDownloadguidelinecomplementary-medicines
7.02Roadmap for CMs08/12/20212pdfDownloadguidelinecomplementary-medicines
SAHPGL-BAU-01Reliance Guideline06/08/20255pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines
SAHPGL-INSP-02SA Guide to Good Manufacturing Practice for Medicines29/09/20229, , pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines inspectorate-and-good-manufacturing-practices licencing
SAHPGL-PEM-01Availability of medicines for use in a Public Health Emergency (PHE)21/08/20233, , , pdfDownloadguidelineemergency-use general-ectd-human-medicines-guidelines section-21 unregistered-products
SAHPGL-PEM-03Guideline for the API Master File (APIMF) Procedure23/07/20244, , pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines pem-pre-reg pharmaceutical-evaluation-management
2.58Submission in eSubmission format18/07/20191Downloadguidelinegeneral-ectd-human-medicines-guidelines
2.23Guideline for submission in eCTD format18/07/20193Downloadguidelinegeneral-ectd-human-medicines-guidelines
SAHGPL-HPA-03eCTD Validation Criteria16/11/20224, pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines hpa
SAHPGL-CEM-02Guideline for Professional Information for Human Medicines (Categories A and D)26/04/20246, , pdfDownloadguidelineclinical-evaluations-management general-ectd-human-medicines-guidelines health-products-authorisation
SAHPGL-CEM-03Guideline for Patient Information Leaflet for Human Medicines (Categories A D)27/05/20248, , pdfDownloadguidelineclinical-evaluations-management general-ectd-human-medicines-guidelines health-products-authorisation
SAHPGL-CEM-01Clinical guideline24/08/20223, pdfDownloadguidelineclinical-evaluations-management general-ectd-human-medicines-guidelines
SAHPGL-HPA-06Variations Addendum For Human And Veterinary Medicines14/09/20226, , pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines hpa veterinary-medicines
SAHPGL-PEM-02Quality and Bioequivalence guideline23/05/20238, pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines veterinary-medicines
SAHPGL-HPA-07General Information Guideline11/12/202312, pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines hpa
Industry Communication on Interim Measures Pending Update of Variation Addendum, 10/09/20201pdfDownloadcommunication-to-industry guidelinegeneral-ectd-human-medicines-guidelines
SAHPGL-PEM-BIO-05Biological Medicines Amendment Guideline07/09/20225pdfDownloadguidelinebiological-medicines-evaluation-and-research
SAHPGL-PEM-BIO-04Biological medicines stability Guideline18/08/20222pdfDownloadguidelinebiological-medicines-evaluation-and-research
SAHPGL-PEM-BIO-03Guideline for Pre-Registration Consultation Meeting13/09/20222pdfDownloadguidelinebiological-medicines-evaluation-and-research
SAHPGL-CEM-NS-04Scheduling of substances for prescribing by authorised prescribers other than medical practitioners or dentists04/05/20223pdfDownloadguidelinenames-and-scheduling
SAHPGL-CEM-NS-02Guideline to the scheduling of substances and medicines11/05/20223pdfDownloadguidelinenames-and-scheduling
2.30Biosimilar Medicines Guidance14/08/20203pdfDownloadguidelinebiological-medicines-evaluation-and-research
SAHPGL-CEM-NS-03Guideline for proprietary names for medicines10/05/20227pdfDownloadguidelinenames-and-scheduling
7.01Complementary Medicines – Discipline Specific Safety and efficacy25/06/20203pdfDownloadguidelinecomplementary-medicines
8.02 (Archived)Medical Device IVD Essential Principles14/11/20192Downloadguidelinemedical-devices