| 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 |
| 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 |
| 9.127 | eCTD Implementation roadmap communication | Communication to industry | 2021 Oct
| 2 | General ECTD & human medicines | | Download | communication-to-industry | general-ectd-human-medicines-guidelines |
| 9.128 | Pilot: BAU new medicine applications for registration | Communication to industry | 2021 Jul
| 2 | General ECTD & human medicines | | Download | communication-to-industry | general-ectd-human-medicines-guidelines |
| 9.129 | Re-submission of BAU New Medicines Applications from 2018 and 2019 | Communication to industry | 2021 Oct
| 2 | General ECTD & human medicines | | Download | communication-to-industry | general-ectd-human-medicines-guidelines |
| SAHPRA INVOLVEMENT IN THE SWISSMEDIC MARKETING AUTHORISATION FOR GLOBAL HEALTH PRODUCTS (MAGHP) PROCEDURE | Communication to industry | 2021 Nov
| 1 | General ECTD & human medicines | pdf | Download | communication-to-industry | general-ectd-human-medicines-guidelines |
| 2.17 | Communication to industry on the sartans-containing medicines | Communication to industry | 2020 Oct
| 2 | General ECTD & human medicines | pdf | Download | communication-to-industry | general-ectd-human-medicines-guidelines |
| 2.18 | Communication to industry on ranitidine-containing medicines | Communication to industry | 2020 Oct
| 1 | General ECTD & human medicines | pdf | Download | communication-to-industry | general-ectd-human-medicines-guidelines |
| 2.19 | Communication to industry on metformin-containing medicines | Communication to industry | 2020 Oct
| 1 | General ECTD & human medicines | pdf | Download | communication-to-industry | general-ectd-human-medicines-guidelines |
| Communication to industry on Clones and Replicas | Communication to industry | 2020 Nov
| 1 | General ECTD & human medicines | pdf | Download | communication-to-industry | general-ectd-human-medicines-guidelines |
| HPA03 | Priority Review Requests Communication | Communication to industry | 2022 Feb
| 2 | General ECTD & human medicines | pdf | Download | communication-to-industry | general-ectd-human-medicines-guidelines |
| Payment of annual retention fees for registered products | Communication to industry | 2022 May
| 1 | General ECTD & human medicines | pdf | Download | communication-to-industry | general-ectd-human-medicines-guidelines |
| Retention Fee Notification – 9 June 2022 | Communication to industry | 2022 Jun
| 1 | Biological Medicines Evaluation and Research, General ECTD & human medicines, Inspectorate and good manufacturing practices, Medical Devices | pdf | Download | communication-to-industry | biological-medicines-evaluation-and-research general-ectd-human-medicines-guidelines inspectorate-and-good-manufacturing-practices medical-devices |
| Communication on Medicines Registration Renewals Implementation Framework | Communication to industry | 2022 Nov
| 2 | Biological Medicines Evaluation and Research, General ECTD & human medicines, Quality, Veterinary medicines | pdf | Download | communication-to-industry | biological-medicines-evaluation-and-research general-ectd-human-medicines-guidelines quality veterinary-medicines |
| Communication to Industry on Nitrosamine Review for New Applications and Registered Products including Biologicals | Communication to industry | 2022 Jun
| 1 | General ECTD & human medicines | pdf | Download | communication-to-industry | general-ectd-human-medicines-guidelines |
| Expression Of Interest: SADC Medicines Regulatory Worksharing, Zazibona Collaborative Process | Communication to industry, Expression of interest | 2019 Oct
| 1 | General ECTD & human medicines | pdf | Download | communication-to-industry expression-of-interest | general-ectd-human-medicines-guidelines |
| Missing Applications – Call to Industry | Communication to industry | 2022 Aug
| 1 | Corporate, General ECTD & human medicines, Information Technology | pdf | Download | communication-to-industry | corporate general-ectd-human-medicines-guidelines information-technology |
| Extension on commentary period for Borderline Products Guideline | Communication to industry | 2022 Sep
| 1 | Corporate, General ECTD & human medicines | pdf | Download | communication-to-industry | corporate general-ectd-human-medicines-guidelines |
| Over-arching: Good Review Practice Guide | Communication to industry, Guide | 2022 Jun
| 1 | Corporate, General ECTD & human medicines | pdf | Download | communication-to-industry guide | corporate general-ectd-human-medicines-guidelines |
| Position Paper – Proposal to Applicants for Dossier Processing Fee (ZaZiBoNa) | Communication to industry | 2022 Oct
| 1 | General ECTD & human medicines | docx | Download | communication-to-industry | general-ectd-human-medicines-guidelines |
| HPA07 | Certification Variation Screening – Type II Proprietary name change applications and TOA’s | Communication to industry | 2022 Oct
| 1 | General ECTD & human medicines | pdf | Download | communication-to-industry | general-ectd-human-medicines-guidelines |
| Renewals Frequently Asked Questions (FAQs) | Communication to industry, FAQ | 2022 Nov
| 1 | Biological Medicines Evaluation and Research, General ECTD & human medicines, Quality, Veterinary medicines | pdf | Download | communication-to-industry faq | biological-medicines-evaluation-and-research general-ectd-human-medicines-guidelines quality veterinary-medicines |
| Expression of Interest-WHO Pre-Qualification Collaborative Registration Procedure | Communication to industry | 2022 Nov
| 1 | General ECTD & human medicines | pdf | Download | communication-to-industry | general-ectd-human-medicines-guidelines |
| Certification Variation Screening – Type II Proprietary Name Change Applications and TOAs | Communication to industry | 2022 Dec
| 2 | General ECTD & human medicines | pdf | Download | communication-to-industry | general-ectd-human-medicines-guidelines |
| HPA09 | Pre-registration veterinary medicines tracker guide | Communication to industry | 2022 Dec
| 1 | General ECTD & human medicines, Veterinary medicines | pdf | Download | communication-to-industry | general-ectd-human-medicines-guidelines veterinary-medicines |
