| Industry Communication on Interim Measures Pending Update of Variation Addendum | Communication to industry, Guideline | 2020 Sep
| 1 | General ECTD & human medicines | pdf | Download | communication-to-industry guideline | general-ectd-human-medicines-guidelines |
| 2.01 | General information guideline | Guideline | 2019 Jul
| 10 | General ECTD & human medicines | | Download | guideline | general-ectd-human-medicines-guidelines |
| 2.02 | Quality and Bioequivalence | Guideline | 2019 Jul
| 7 | General ECTD & human medicines | | Download | guideline | general-ectd-human-medicines-guidelines |
| SAHPGL-HPA-06 | Variations Addendum For Human And Veterinary Medicines | Guideline | 2022 Sep
| 6 | General ECTD & human medicines, Veterinary medicines | pdf | Download | guideline | general-ectd-human-medicines-guidelines veterinary-medicines |
| SAHPGL-CEM-01 | Clinical guideline | Guideline | 2022 Aug
| 3 | Clinical Evaluations Management, General ECTD & human medicines | pdf | Download | guideline | clinical-evaluations-management general-ectd-human-medicines-guidelines |
| SAHPGL-CEM-03 | Guideline for Patient Information Leaflet for Human Medicines (Categories A D) | Guideline | 2022 oct
| 7 | Clinical Evaluations Management, General ECTD & human medicines, Health Products Authorisation | pdf | Download | guideline | clinical-evaluations-management general-ectd-human-medicines-guidelines health-products-authorisation |
| SAHPGL-CEM-02 | Guideline for Professional Information for Human Medicines (Categories A and D) | Guideline | 2022 Sept
| 5 | Clinical Evaluations Management, General ECTD & human medicines, Health Products Authorisation | pdf | Download | guideline | clinical-evaluations-management general-ectd-human-medicines-guidelines health-products-authorisation |
| SAHGPL-HPA-03 | eCTD Validation Criteria | Guideline | 2022 Nov
| 4 | General ECTD & human medicines | pdf | Download | guideline | general-ectd-human-medicines-guidelines |
| 2.23 | Guideline for submission in eCTD format | Guideline | 2019 Jul
| 3 | General ECTD & human medicines | | Download | guideline | general-ectd-human-medicines-guidelines |
| 2.58 | Submission in eSubmission format | Guideline | 2019 Jul
| 1 | General ECTD & human medicines | | Download | guideline | general-ectd-human-medicines-guidelines |
| SAHPGL-PEM-03 | Guideline for the API Master File (APIMF) Procedure | Guideline | 2022 Nov
| 3 | General ECTD & human medicines, Pharmaceutical Evaluation Management, Pre-Reg | pdf | Download | guideline | general-ectd-human-medicines-guidelines pharmaceutical-evaluation-management pre-reg |
| SAHPGL-PEM-01 | Availability of medicines for use in a Public Health Emergency (PHE) | Guideline | 2022 Jun
| 2 | Emergency use, General ECTD & human medicines, Section 21, Unregistered products | pdf | Download | guideline | emergency-use general-ectd-human-medicines-guidelines section-21 unregistered-products |
| SAHPGL-INSP-02 | Guideline for Good Manufacturing Practice | Guideline | 2022 Sep
| 8 | General ECTD & human medicines, Inspectorate and good manufacturing practices, Licencing | pdf | Download | guideline | general-ectd-human-medicines-guidelines inspectorate-and-good-manufacturing-practices licencing |
| 5.08 | Reliance Guideline | Guideline | 2022 Mar
| 3 | General ECTD & human medicines | | Download | guideline | general-ectd-human-medicines-guidelines |
| SAHPGL-HPA-05 | BAU Variations Communication | Communication to industry, Guideline | 2022 Sep
| 4 | General ECTD & human medicines | pdf | Download | communication-to-industry guideline | general-ectd-human-medicines-guidelines |
| 2.40 | Multiple submissions of the same application for registration with different proprietary names | Guideline | 2019 May
| 4 | General ECTD & human medicines | | Download | guideline | general-ectd-human-medicines-guidelines |
| SAHPGL-HPA-04 | Renewal of Human and Veterinary Medicines Requirements and Process | Guideline | 2022 Jun
| 1 | General ECTD & human medicines, Veterinary medicines | pdf | Download | guideline | general-ectd-human-medicines-guidelines veterinary-medicines |
| 2.21 | South African Specification for eCTD Regional Module1 | Guideline | 2019 May
| 3 | General ECTD & human medicines | | Download | guideline | general-ectd-human-medicines-guidelines |
