Guidelines

BIOLOGICAL MEDICINES

Document NumberTitleCategoriesDate updatedVersionUnitsFile TypeLinkdoc_categories_hfilterdoc_tags_hfilter
9.126Reflection document on regulatory requirements for vaccines intended to provide protection against variant strain(s) of SARS-CoV-2

2021 May

1pdfDownloadguidelinebiological-medicines-evaluation-and-research
SAHPGL-CEM-NS-03Guideline for proprietary names for medicines

2022 May

7, pdfDownloadguidelinebiological-medicines-evaluation-and-research names-and-scheduling
2.30Biosimilar Medicines Guidance

2014 Aug

3pdfDownloadguidelinebiological-medicines-evaluation-and-research
SAHPGL-CEM-NS-02Guideline to the scheduling of substances and medicines

2022 May

3, pdfDownloadguidelinebiological-medicines-evaluation-and-research names-and-scheduling
SAHPGL-CEM-NS-04Scheduling of substances for prescribing by authorised prescribers other than medical practitioners or dentists

2022 May

3, pdfDownloadguidelinebiological-medicines-evaluation-and-research names-and-scheduling
2.39Biological Medicines Pre-Registration Consultation Meeting Guidance

2020 May

1pdfDownloadguidelinebiological-medicines-evaluation-and-research
2.60Biological Medicines Stability Guideline

2020 Oct

1pdfDownloadguidelinebiological-medicines-evaluation-and-research
2.61Biological medicines amendment guideline

2021 Mar

4pdfDownloadguidelinebiological-medicines-evaluation-and-research
6.20Pre-Registration Consultation Meeting Material Checklist

2014 Jun

1pdfDownloadguidelinebiological-medicines-evaluation-and-research
2.40Multiple submissions of the same application for registration with different proprietary names

2019 May

4pdfDownloadguidelinebiological-medicines-evaluation-and-research
2.67Guidance document on quality safety and efficacy requirements for Biological Medicines

2022 Apr

1pdfDownloadguidelinebiological-medicines-evaluation-and-research
SAHPGL-PEM-BIO-01Guideline for Lot release of human vaccines

2022 Apr

2, pdfDownloadguidelinebiological-medicines-evaluation-and-research general-ectd-human-medicines-guidelines
Communication on Medicines Registration Renewals Implementation Framework,

June 2022

1, , , pdfDownloadcommunication-to-industry guidelinebiological-medicines-evaluation-and-research general-ectd-human-medicines-guidelines quality veterinary-medicines
SAHPGL-HPA-04Renewal of Human and Veterinary Medicines Requirements and Process

2022 Jun

1, , pdfDownloadguidelinebiological-medicines-evaluation-and-research general-ectd-human-medicines-guidelines veterinary-medicines

COMPLEMENTARY

CLINICAL TRIALS

Document NumberTitleCategoriesDate updatedVersionUnitsFile TypeLinkdoc_categories_hfilterdoc_tags_hfilter
2.09Clinical guideline

2019 Jul

2, pdfDownloadguidelineclinical-trials general-ectd-human-medicines-guidelines
SA GCP Guidelines

2020 Jun

3pdfDownloadguidelineclinical-trials
Clinical Trials Committee and Submission dates for 2022

2021 Jun

1pdfDownloadguidelineclinical-trials
2.11Safety Reporting During Clinical Trials

2021 Aug

4pdfDownloadguidelineclinical-trials
2.41Emergency Procedures for Clinical Trial Sites

2019 May

2pdfDownloadguidelineclinical-trials
2.42Post Clinical Trial Access

2019 Apr

2pdfDownloadguidelineclinical-trials
2.43Oversight and Monitoring in Clinical Trials

2021 Mar

3pdfDownloadguidelineclinical-trials
2.49Capacity Building and Transformation during Clinical Trials

2019 Jul

1pdfDownloadguidelineclinical-trials
2.51Clinical Trial Participant Time, Inconvenience and Expense (TIE) Compensation Model

2018 May

1pdfDownloadguidelineclinical-trials
2.55Liability Insurance for Clinical Trials

2019 Nov

1pdfDownloadguidelineclinical-trials
6.29Procedure for Consultation Meetings with Clinical Trial Applicants

2019 Nov

1pdfDownloadguidelineclinical-trials
9.59Electronic submission of clinical trials,

2019 Apr

2pdfDownloadcommunication-to-industry guidelineclinical-trials
9.84Clinical Trial Investigators,

2019 May

2pdfDownloadcommunication-to-industry guidelineclinical-trials

GENERAL, ECTD & HUMAN MEDICINES

Document NumberTitleCategoriesDate updatedVersionUnitsFile TypeLinkdoc_categories_hfilterdoc_tags_hfilter
Industry Communication on Interim Measures Pending Update of Variation Addendum,

2020 Sep

1pdfDownloadcommunication-to-industry guidelinegeneral-ectd-human-medicines-guidelines
2.01General information guideline

2019 Jul

10pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines
2.02Quality and Bioequivalence

2019 Jul

7pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines
2.08Variations Addendum for Human and Veterinary Medicines

2022 Feb

5, pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines veterinary-medicines
2.09Clinical guideline

2019 Jul

2, pdfDownloadguidelineclinical-trials general-ectd-human-medicines-guidelines
2.14Guideline for Patient Information Leaflet for Human Medicines

2019 Jul

2, pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines health-products-authorisation
2.16Guideline for Professional Information for Human Medicines

2019 Jul

2, pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines health-products-authorisation
2.22eCTD Validation Criteria

2016 Sep

2pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines
2.23Guideline for submission in eCTD format

2019 Jul

3pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines
2.58Submission in eSubmission format

2019 Jul

1pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines
2.59Guideline for the APIMF Procedure

2021 Jan

2pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines
SAHPGL-PEM-01Availability of medicines for use in a Public Health Emergency (PHE)

2022 Jun

2, , pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines section-21 unregistered-products
4.01SA Guide to Good Manufacturing Practice

2019 Jul

7, pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines inspectorate-and-good-manufacturing-practices
5.08Reliance Guideline

2022 Mar

3pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines
9.125BAU variations communication,

2022 Feb

3pdfDownloadcommunication-to-industry guidelinegeneral-ectd-human-medicines-guidelines
9.127eCTD Implementation roadmap communication

2021 Oct

2pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines
9.128Pilot: BAU new medicine applications for registration

2021 Jul

2pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines
9.129Re-submission of BAU New Medicines Applications from 2018 and 2019

2021 Oct

2pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines
2.07Dissolution

2015 Jun

5pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines
9.132Priority Review Requests Communication,

2022 Feb

1pdfDownloadcommunication-to-industry guidelinegeneral-ectd-human-medicines-guidelines
SAHPGL-PEM-BIO-01Guideline for Lot release of human vaccines

2022 Apr

2, pdfDownloadguidelinebiological-medicines-evaluation-and-research general-ectd-human-medicines-guidelines
Communication on Medicines Registration Renewals Implementation Framework,

June 2022

1, , , pdfDownloadcommunication-to-industry guidelinebiological-medicines-evaluation-and-research general-ectd-human-medicines-guidelines quality veterinary-medicines
SAHPGL-HPA-04Renewal of Human and Veterinary Medicines Requirements and Process

2022 Jun

1, , pdfDownloadguidelinebiological-medicines-evaluation-and-research general-ectd-human-medicines-guidelines veterinary-medicines

INSPECTORATE AND GOOD MANUFACTURING PRACTICES

Document NumberTitleCategoriesDate updatedVersionUnitsFile TypeLinkdoc_categories_hfilterdoc_tags_hfilter
4.01SA Guide to Good Manufacturing Practice

2019 Jul

7, pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines inspectorate-and-good-manufacturing-practices
How to Respond to a GMP, GWP or GCP Inspection Report

2019 Nov

1pdfDownloadguidelineinspectorate-and-good-manufacturing-practices
2.04Post importation testing guideline

2021 Aug

4pdfDownloadguidelineinspectorate-and-good-manufacturing-practices
4.02South African Good Wholesaling Practice for Wholesalers

2019 Nov

2, pdfDownloadguidelineinspectorate-and-good-manufacturing-practices licencing
4.03Aerosol Manufacturing

2019 Nov

1pdfDownloadguidelineinspectorate-and-good-manufacturing-practices
4.04Isolator technology

2003 Jun

1pdfDownloadguidelineinspectorate-and-good-manufacturing-practices
4.05Cephalosporin manufacture

2019 Nov

1pdfDownloadguidelineinspectorate-and-good-manufacturing-practices
4.06Penicillin manufacture

2019 Nov

1pdfDownloadguidelineinspectorate-and-good-manufacturing-practices
4.07Radiopharmaceutical manufacture

2019 Nov

1pdfDownloadguidelineinspectorate-and-good-manufacturing-practices
4.08Site master file

2019 Nov

1, pdfDownloadguidelineinspectorate-and-good-manufacturing-practices licencing
4.09Inspections involving GMP inspectors

2019 Nov

1pdfDownloadguidelineinspectorate-and-good-manufacturing-practices
4.10Wholesalers to Export Medicinal Products

2015 Oct

1pdfDownloadguidelineinspectorate-and-good-manufacturing-practices
4.11HOW TO RESPOND TO A GMP,GWP OR GCP INSPECTION REPORT

2019 Feb

1pdfDownloadguidelineinspectorate-and-good-manufacturing-practices
4.13Guide to Fee Determination and Payments Of GxP and Product-Related Inspections

2021 Aug

1pdfDownloadguidelineinspectorate-and-good-manufacturing-practices

MEDICAL DEVICES AND IN VITRO DIAGNOSTICS

Document NumberTitleCategoriesDate updatedVersionUnitsFile TypeLinkdoc_categories_hfilterdoc_tags_hfilter
8.02Medical Device IVD Essential Principles

2019 Nov

2pdfDownloadguidelinemedical-devices
5.08Revised Guideline – DONATION OF MEDICINES MEDICAL DEVICES AND IVDs,

2020 Apr

3pdfDownloadcommunication-to-industry guidelinemedical-devices
8.04Recalls Vigilance Medical Devices IVDs

2019 Nov

3pdfDownloadguidelinemedical-devices
8.05CLASSIFICATION of MEDICAL DEVICES and IVDs

2021 Aug

5pdfDownloadguidelinemedical-devices
8.07Medical Device Quality Manual

2019 Nov

2pdfDownloadguidelinemedical-devices
004MD004 – Extension – Use of acknowledgement letter in lieu of a licence,

2020 Mar

1pdfDownloadcommunication-to-industry guidelinemedical-devices
010MD010 – Guidance Rapidly developed ventilator,

2020 May

1pdfDownloadcommunication-to-industry guidelinemedical-devices
16.03Licence Medical Devices IVDs

2019 Nov

3pdfDownloadguidelinemedical-devices

NAMES AND SCHEDULING

Document NumberTitleCategoriesDate updatedVersionUnitsFile TypeLinkdoc_categories_hfilterdoc_tags_hfilter
SAHPGL-CEM-NS-03Guideline for proprietary names for medicines

2022 May

7, pdfDownloadguidelinebiological-medicines-evaluation-and-research names-and-scheduling
SAHPGL-CEM-NS-02Guideline to the scheduling of substances and medicines

2022 May

3, pdfDownloadguidelinebiological-medicines-evaluation-and-research names-and-scheduling
SAHPGL-CEM-NS-04Scheduling of substances for prescribing by authorised prescribers other than medical practitioners or dentists

2022 May

3, pdfDownloadguidelinebiological-medicines-evaluation-and-research names-and-scheduling
SAHPGL-CEM-NS-01Application for rescheduling of a substance or medicine

2022 May

1pdfDownloadguidelinenames-and-scheduling

QUALITY MANAGEMENT SYSTEMS

Document NumberTitleCategoriesDate updatedVersionUnitsFile TypeLinkdoc_categories_hfilterdoc_tags_hfilter
SAHPGL-GOV-01Guideline for appeals against Regulatory decisions

2022 Apr

1pdfDownloadguidelinequality-management-system

RADIATION CONTROL

REGULATORY COMPLIANCE

Document NumberTitleCategoriesDate updatedVersionUnitsFile TypeLinkdoc_categories_hfilterdoc_tags_hfilter
SAHPGL-INSP-RC-02Guideline for the Importation and Exportation of Medicines

2022 Jun

2pdfDownloadguidelineregulatory-compliance
5.09GUIDELINE ON HOW TO LODGE A COMPLAINT ON MEDICINES AND MEDICAL DEVICES

2021 Sep

2pdfDownloadguidelineregulatory-compliance
SAHPGL-INSP-RC-05Guidelines for Medicine Recalls – Withdrawals and Rapid Alerts

2022 Jun

3pdfDownloadguidelineregulatory-compliance
SAHPGL-INSP-RC-06 Guideline to Fee Determination and Payments of Permits and Related Authorisations

2022 Jun

1pdfDownloadguidelineregulatory-compliance
SAHPGL-INSP-RC-07Guidelines for Advertisement of Medicines and Health Products

2022 Jun

2pdfDownloadguidelineregulatory-compliance
SAHPGL-INS-RC-11Guideline for Release of Import Health Products at Ports of Entry

2022 Jun

2pdfDownloadguidelineregulatory-compliance
SAHPGL-INS-RC-1Guidelines for Market Surveillance Of Medicines

2022 Jun

2pdfDownloadguidelineregulatory-compliance

UNREGISTERED PRODUCTS

Document NumberTitleCategoriesDate updatedVersionUnitsFile TypeLinkdoc_categories_hfilterdoc_tags_hfilter
SAHPGL-PEM-01Availability of medicines for use in a Public Health Emergency (PHE)

2022 Jun

2, , pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines section-21 unregistered-products
Section 21 Access to Unregistered Medicines – IVERMECTIN CONTROLLED COMPASSIONATE USE PROGRAMME,

2021 Jan

1, , pdfDownloadcommunication-to-industry guidelineemergency-use section-21 unregistered-products
2.52Section 21 Access to Unregistered Medicines

2021 Aug

3, , pdfDownloadguidelineemergency-use section-21 unregistered-products

VETERINARY MEDICINES

VIGILANCE GUIDELINES