The “Documents for Comments” area serves as a space for stakeholders to engage with SAHPRA’s regulatory processes. Your input is valuable as we strive to ensure transparency and inclusivity in our decision-making. Please take the time to review the documents and share your comments. Together, we can contribute to the continuous improvement of healthcare regulation in South Africa.
Document Name | Description | Date Published | Comments Deadline date | Submit to | Comments Form | Document for Comment |
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Guideline for Variations Addendum for Human and Veterinary Medicines 1. Annexure A - Health Products Authorisation (CV) 2. Annexure B - PEM Quality Variations Classification Codes 3. Annexure C - CEM Clinical Variations Classification Codes 4. Annexure D - Names and Scheduling Variations Classification Codes 5. Annexure E - Inspectorate Variations Classification Codes 6. Annexure F - Biological Variation Classification Codes 7. Annexure G - Veterinary Variations Classification Codes | The South African Health Products Regulatory Authority (SAHPRA) has established specific requirements for the submission of amendments/variations to registered products, for human and veterinary medicines, as well as biologicals. This guideline should be read in conjunction with the relevant annexures and SAHPRA guidelines for each specific unit, as well as the latest/revised relevant guidelines and templates listed in Appendix A. The requirements specified in this guideline and its annexures, are aligned to the framework of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), as well as the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). In doing so, SAHPRA will reflect global best practices in terms of the safety, quality and efficacy of health product regulations. | 01 October 2025 | 01 December 2025 | Please submit comments using the comment form. The comments should be submitted to Ketshepile.Serumula@sahpra.org.za or Postregqualityvariations@sahpra.org.za Note to stakeholders: An individual/separate "Guidelines for comment" form must be completed and submitted for each document for comment. | Download comment Form | Guideline for Variations Addendum for Human and Veterinary Medicines 1. Annexure A - Health Products Authorisation (CV) 2. Annexure B - PEM Quality Variations Classification Codes 3. Annexure C - CEM Clinical Variations Classification Codes 4. Annexure D - Names and Scheduling Variations Classification Codes 5. Annexure E - Inspectorate Variations Classification Codes 6. Annexure F - Biological Variation Classification Codes 7. Annexure G - Veterinary Variations Classification Codes |
Guideline for Borderline Products | This guideline is intended to provide information on the process to be followed in caseswhere the appropriate regulatory pathway is unclear for specific products. | 05 September 2025 | 01 December 2025 | Please submit comments using the comment form. The comments should be submitted to gontse.moutloatse@sahpra.org.za | Download comment Form | Download Document for Comment |
Guideline for Labelling of Medicines Intended for Human Use | This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of Human Medicines (categories A and D) containing specified substances, assist applicants with the correct way of presenting the label for evaluation, and enhance consistency in the content of the label. | 12 September 2025 | 06 October 2025 | Please submit comments using the comment form. The comments should be submitted to Aseza.Matolengwe@sahpra.org.za or Dillon.Singh@sahpra.org.za or Karin.Duxbury@sahpra.org.za | Download comment Form | Download Document for Comment |
Transport Security Guideline | This guideline specifies the basic security conditions for obtaining a transport authority for Group IV hazardous substances as defined in the Hazardous Substances Act 15 of 1973, referred to in this guidance as radioactive material. | 19 September 2025 | 19 October 2025 | Please submit comments using the comment form. The comments should be submitted to dithole.seepamore@sahpra.org.za or Fakazi.Nhachissambe@sahpra.org.za or mqondisi.maphophe@sahpra.org.za | Download comment Form | Download Document for Comment |
General Information Guideline | This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of medicines. | 08 September 2025 | 30 September 2025 | Please submit comments using the comment form. The comments should be submitted to Pratibha.Sobrun@sahpra.org.za | Download comment Form | Download Document for Comment |
SA Guide to Good Manufacturing Practice for Medicines | Annexure 16 (Country specific requirements) has been updated for key Personnel appointments and competencies in the GMP/GWP facility | 22 August 2025 | 22 September 2025 | Please submit comments using the comment form. The comments should be submitted to samu.motshitela@sahpra.org.za and Lebohang.mazibuko@sahpra.org.za | Download comment Form | Download Document for Comment |
Guidelines for Preparation of a Site Master File (SMF) for Wholesalers of Medical Devices | The Site Master File (SMF) is prepared by the wholesaler, and it contains specific information about the quality assurance and/or quality control of medical device wholesaling operations carried out at the named site and any closely integrated operations at adjacent and nearby buildings. Extended closing date | 21 May 2025 | 18 September 2025 | Please submit comments using the comment form. The comments should be submitted to mdqueries@sahpra.org.za | Download comment Form | Download Document for Comment |
ICH E21 Guideline on inclusion of pregnant and breastfeeding individuals in clinical trials | At Step 2 of the ICH Process, a consensus draft text or guideline, agreed by the appropriate ICH Expert Working Group, is transmitted by the ICH Assembly to the regulatory authorities of the ICH regions for internal and external consultation, according to national or regional procedures. | 25 July 2025 | 15 September 2025 | Please submit comments using the ICH comment form. The comments should be submitted to SAHPRA at CTCGuidelines@sahpra.org.za and Kedibone.Malatji@sahpra.org.za by 13 August 2025. | Download ICH comment Form | Download Document for Comment |
Guideline for Users of Ultra-Portable X-Ray Equipment | This Guideline sets out requirements for the importation and use of ultra-portable X-ray (UP-XR) and recommendations for radiation safety associated with the use thereof. The document emphasises the importance of radiation safety for UP-XR systems, while ensuring alignment with the World Health Organization’s (WHO) and International Atomic Energy Agency (IAEA) principles of radiation protection. | 15 September 2025 | 15 October 2025 | Please submit comments using the X-ray comment form. The comments should be submitted to SAHPRA: mqondisi.maphophe@sahpra.org.za by 15 October 2025. | Download X-ray comment Form | Download Document for Comment |