| Notification Template 1 for Nitrosamine Risk Evaluation | Templates | 2021 Dec
| 1 | General ECTD & human medicines | | Download | templates | general-ectd-human-medicines-guidelines |
| Notification Template 2 for Nitrosamine Confirmatory Testing | Templates | 2021 Dec
| 1 | General ECTD & human medicines | | Download | templates | general-ectd-human-medicines-guidelines |
| Outcome of Risk for Nitrosamine Investigation | Templates | 2021 Dec
| 1 | General ECTD & human medicines | | Download | templates | general-ectd-human-medicines-guidelines |
| SAHPRA Variation Validation Template for eCTD | Templates | 2020 Feb
| 1 | General ECTD & human medicines | | Download | templates | general-ectd-human-medicines-guidelines |
| SAHPRA Variation Validation Template for eSubmission | Templates | 2020 Feb
| 1 | General ECTD & human medicines | | Download | templates | general-ectd-human-medicines-guidelines |
| 6.16 | New Registration Validation Template for eCTD | Templates | 2019 Jul
| 3 | General ECTD & human medicines | | Download | templates | general-ectd-human-medicines-guidelines |
| 6.30 | New Registration Validation Template for eSubmission | Templates | 2019 Jul
| 1 | General ECTD & human medicines | | Download | templates | general-ectd-human-medicines-guidelines |
| 6.31 | Summary of Critical Regulatory Elements (SCoRE) | Templates | 2020 Nov
| 3 | General ECTD & human medicines | | Download | templates | general-ectd-human-medicines-guidelines |
| OF-PEM-PRE-01J | Bioequivalence Trial Information Form (BTIF) | Form, Templates | 2022 Aug
| 4 | General ECTD & human medicines, Pharmaceutical Evaluation Management | docx | Download | form templates | general-ectd-human-medicines-guidelines pharmaceutical-evaluation-management |
| 6.33 | Abridged review template | Templates | 2019 Aug
| 2 | General ECTD & human medicines | | Download | templates | general-ectd-human-medicines-guidelines |
| 6.34 | Verified review template | Templates | 2019 Aug
| 2 | General ECTD & human medicines | | Download | templates | general-ectd-human-medicines-guidelines |
| OF-PEM-PRE-01H | Additional Strength Biowaiver Application Form | Form, Templates | 2022 Aug
| 4 | General ECTD & human medicines, Pharmaceutical Evaluation Management | docx | Download | form templates | general-ectd-human-medicines-guidelines pharmaceutical-evaluation-management |
| OF-PEM-PRE-01I | Biopharmaceutics Classification System (BCS) Based Biowaiver Application Form | Form, Templates | 2022 Aug
| 4 | General ECTD & human medicines, Pharmaceutical Evaluation Management | docx | Download | form templates | general-ectd-human-medicines-guidelines pharmaceutical-evaluation-management |
| Conformity of assessment body DoC template | Communication to industry, Templates | 2022 Mar
| 1 | Medical Devices | docx | Download | communication-to-industry templates | medical-devices |
| Veterinary Clinical Trial Application Template | Templates | 2019 Dec
| 2 | Clinical Trials, Veterinary medicines | | Download | templates | clinical-trials veterinary-medicines |
| OF-PEM-VET-04B | Veterinary Medicines Biowaiver Application Form for Parenterals | Templates | 2022 Sept
| 1 | Veterinary medicines | docx | Download | templates | veterinary-medicines |
| GLF-PEM-VET-04A | Residue Overall Summary (ROS) | Templates | 2022 Sept
| 1 | Veterinary medicines | docx | Download | templates | veterinary-medicines |
| OF-PEM-VET-04A | Bioequivalence Trial Information for Veterinary Medicines | Templates | 2022 Sept
| 1 | Veterinary medicines | docx | Download | templates | veterinary-medicines |
