| 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 | pdf | Download | guideline | general-ectd-human-medicines-guidelines |
| 2.02 | Quality and Bioequivalence | Guideline | 2019 Jul
| 7 | General ECTD & human medicines | pdf | Download | guideline | general-ectd-human-medicines-guidelines |
| 2.08 | Variations Addendum for Human and Veterinary Medicines | Guideline | 2022 Feb
| 5 | General ECTD & human medicines, Veterinary medicines | pdf | Download | guideline | general-ectd-human-medicines-guidelines veterinary-medicines |
| 2.09 | Clinical guideline | Guideline | 2019 Jul
| 2 | Clinical Trials, General ECTD & human medicines | pdf | Download | guideline | clinical-trials general-ectd-human-medicines-guidelines |
| 2.14 | Guideline for Patient Information Leaflet for Human Medicines | Guideline | 2019 Jul
| 2 | General ECTD & human medicines, Health Products Authorisation | pdf | Download | guideline | general-ectd-human-medicines-guidelines health-products-authorisation |
| 2.16 | Guideline for Professional Information for Human Medicines | Guideline | 2019 Jul
| 2 | General ECTD & human medicines, Health Products Authorisation | pdf | Download | guideline | general-ectd-human-medicines-guidelines health-products-authorisation |
| 2.22 | eCTD Validation Criteria | Guideline | 2016 Sep
| 2 | 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 | pdf | Download | guideline | general-ectd-human-medicines-guidelines |
| 2.58 | Submission in eSubmission format | Guideline | 2019 Jul
| 1 | General ECTD & human medicines | pdf | Download | guideline | general-ectd-human-medicines-guidelines |
| 2.59 | Guideline for the APIMF Procedure | Guideline | 2021 Jan
| 2 | General ECTD & human medicines | pdf | Download | guideline | general-ectd-human-medicines-guidelines |
| SAHPGL-PEM-01 | Availability of medicines for use in a Public Health Emergency (PHE) | Guideline | 2022 Jun
| 2 | General ECTD & human medicines, Section 21, Unregistered products | pdf | Download | guideline | general-ectd-human-medicines-guidelines section-21 unregistered-products |
| 4.01 | SA Guide to Good Manufacturing Practice | Guideline | 2019 Jul
| 7 | General ECTD & human medicines, Inspectorate and good manufacturing practices | pdf | Download | guideline | general-ectd-human-medicines-guidelines inspectorate-and-good-manufacturing-practices |
| 5.08 | Reliance Guideline | Guideline | 2022 Mar
| 3 | General ECTD & human medicines | pdf | Download | guideline | general-ectd-human-medicines-guidelines |
| 9.125 | BAU variations communication | Communication to industry, Guideline | 2022 Feb
| 3 | General ECTD & human medicines | pdf | Download | communication-to-industry guideline | general-ectd-human-medicines-guidelines |
| 9.127 | eCTD Implementation roadmap communication | Guideline | 2021 Oct
| 2 | General ECTD & human medicines | pdf | Download | guideline | general-ectd-human-medicines-guidelines |
| 9.128 | Pilot: BAU new medicine applications for registration | Guideline | 2021 Jul
| 2 | General ECTD & human medicines | pdf | Download | guideline | general-ectd-human-medicines-guidelines |
| 9.129 | Re-submission of BAU New Medicines Applications from 2018 and 2019 | Guideline | 2021 Oct
| 2 | General ECTD & human medicines | pdf | Download | guideline | general-ectd-human-medicines-guidelines |
| 2.07 | Dissolution | Guideline | 2015 Jun
| 5 | General ECTD & human medicines | pdf | Download | guideline | general-ectd-human-medicines-guidelines |
| 9.132 | Priority Review Requests Communication | Communication to industry, Guideline | 2022 Feb
| 1 | General ECTD & human medicines | pdf | Download | communication-to-industry guideline | general-ectd-human-medicines-guidelines |
| SAHPGL-PEM-BIO-01 | Guideline for Lot release of human vaccines | Guideline | 2022 Apr
| 2 | Biological Medicines Evaluation and Research, General ECTD & human medicines | pdf | Download | guideline | biological-medicines-evaluation-and-research general-ectd-human-medicines-guidelines |
| Communication on Medicines Registration Renewals Implementation Framework | Communication to industry, Guideline | June 2022
| 1 | Biological Medicines Evaluation and Research, General ECTD & human medicines, Quality, Veterinary medicines | pdf | Download | communication-to-industry guideline | biological-medicines-evaluation-and-research general-ectd-human-medicines-guidelines quality veterinary-medicines |
| SAHPGL-HPA-04 | Renewal of Human and Veterinary Medicines Requirements and Process | Guideline | 2022 Jun
| 1 | Biological Medicines Evaluation and Research, General ECTD & human medicines, Veterinary medicines | pdf | Download | guideline | biological-medicines-evaluation-and-research general-ectd-human-medicines-guidelines veterinary-medicines |
