XR01-2024/25 | Introduction of Conditions for Veterinary X-Ray Licence Holders | Communication to industry | 06/12/2024 | 1 | Radiation Control, x-rays | pdf | Download | communication-to-industry | radiation-control x-rays |
RC02-2024/2025 | Absence of Border Medicines Control Technicians at the Ports of Entry on 29 November 2024 | Communication to industry | 25/11/2024 | 1 | Inspectorate and good manufacturing practices, Regulatory Compliance | pdf | Download | communication-to-industry | inspectorate-and-good-manufacturing-practices regulatory-compliance |
FN02-2024/25 | Submission Dates for Claims | Communication to industry | 22/11/2024 | 1 | Finance | pdf | Download | communication-to-industry | finance |
PEM POST 04-2024/25 | Quality Variations | Communication to industry | 11/11/2024 | 1 | General ECTD & human medicines, PEM Post-Reg | pdf | Download | communication-to-industry | general-ectd-human-medicines-guidelines pem-post-reg |
HPA16-2024/25 | SAHPRA Engagement Portal | Communication to industry | 07/11/2024 | 1 | General ECTD & human medicines, HPA | pdf | Download | communication-to-industry | general-ectd-human-medicines-guidelines hpa |
HPA15-2024/25 | Implementation of Regulatory Information Management System – Information on eCTD 3.1 Module 1 – Document Matrix | Communication to industry | 29/10/2024 | 8 | General ECTD & human medicines, HPA | pdf | Download | communication-to-industry | general-ectd-human-medicines-guidelines hpa |
HPA15-2024/25 | Communication to Industry – Implementation of RIMS – Information on eCTD 3.1 Module 1 | Communication to industry | 25/10/2024 | 7 | General ECTD & human medicines, HPA | pdf | Download | communication-to-industry | general-ectd-human-medicines-guidelines hpa |
CT03-2024/25 | Clinical Trials Committee Meeting and Submission Dates for 2025 | Communication to industry | 14/10/2024 | 1 | Clinical Evaluations Management, Clinical Trials | pdf | Download | communication-to-industry | clinical-evaluations-management clinical-trials |
VET01-2024/25 | Communication to Industry – Request for Scientific Information on Yohimbine Use in Veterinary Medicine | Communication to industry | 11/10/2024 | 1 | Veterinary medicines | pdf | Download | communication-to-industry | veterinary-medicines |
CT02-2024/25 | Clinical Trial Applications – Investigational Product Import Licence | Communication to industry | 25/09/2024 | 1 | Clinical Evaluations Management, Clinical Trials | pdf | Download | communication-to-industry | clinical-evaluations-management clinical-trials |
| Communication to Industry – Policy Position of SAHPRA on Enabling Local Manufacture | Communication to industry | 17/09/2024 | 1 | Corporate | pdf | Download | communication-to-industry | corporate |
MD01-2023/24 | Mpox Diagnostic Tests | Communication to industry | 13/09/2024 | 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
CLINPR02-2024/25 | Phenylephrine Lack of Effectiveness of Oral Preparations as Nasal Decongestant | Communication to industry | 01/08/2024 | 1 | Clinical Evaluations Management, General ECTD & human medicines | pdf | Download | communication-to-industry | clinical-evaluations-management general-ectd-human-medicines-guidelines |
CLINPR01-2024/25 | Restriction on Codeine Use in Children, Pregnant and/or Breastfeeding Mothers | Communication to industry | 01/08/2024 | 1 | Clinical Evaluations Management, General ECTD & human medicines | pdf | Download | communication-to-industry | clinical-evaluations-management general-ectd-human-medicines-guidelines |
PEM-POST-02-2024_25 | Communication to Industry – FAQs on Active Pharmaceutical Ingredient | Communication to industry | 23/07/2024 | 1 | General ECTD & human medicines | pdf | Download | communication-to-industry | general-ectd-human-medicines-guidelines |
PEM-POST-01-2024/25 | Frequently asked questions (FAQs) and common deficiencies for the submission of PEM Post-Registration variations | Communication to industry, FAQ | 23/07/2024 | 5 | General ECTD & human medicines, PEM Post-Reg | pdf | Download | communication-to-industry faq | general-ectd-human-medicines-guidelines pem-post-reg |
| B-BBEE Policy for Issuance of Licences – for further comments | Communication to industry | 09/07/2024 | 2 | Legal | pdf | Download | communication-to-industry | legal |
HPA-15 | Communication to Industry – Implementation of the Regulatory Information Management System, Version 5 Portal & Interim DVP use | Communication to industry | 09/07/2024 | 5 | General ECTD & human medicines, HPA | pdf | Download | communication-to-industry | general-ectd-human-medicines-guidelines hpa |
HPA-16 | ZA-SAHPRA CTD eSubmission Specification – Document for comment | Communication to industry | 06/06/2024 | 3 | General ECTD & human medicines, HPA | pdf | Download | communication-to-industry | general-ectd-human-medicines-guidelines hpa |
MD01-2024/2025 | Contact details for Guideline SAHPGL-MD-03 Medical Device Vigilance: Adverse Events Reporting for License Holders | Communication to industry | 09/07/2024 | 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
HPA-15 | Communication to Industry – Implementation of Regulatory Information Management System – Update on Progress | Communication to industry | 28/05/2024 | 6 | General ECTD & human medicines, HPA | pdf | Download | communication-to-industry | general-ectd-human-medicines-guidelines hpa |
| Expression of Interest for Medical Device Registration Voluntary Feasibility Study | Communication to industry | 17/05/2024 | 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
RC02-2024/2025 | Physical Resubmission of Shipment Documentation for SAHPRA Review and Stamp | Communication to industry | 16/05/2024 | 1 | Inspectorate and good manufacturing practices, Regulatory Compliance | pdf | Download | communication-to-industry | inspectorate-and-good-manufacturing-practices regulatory-compliance |
RC01-2024/2025 | Delays in Shipment Release at OR Tambo International Airport | Communication to industry | 10/05/2024 | 1 | Inspectorate and good manufacturing practices, Regulatory Compliance | pdf | Download | communication-to-industry | inspectorate-and-good-manufacturing-practices regulatory-compliance |
| Clinical Variations Fee Schedule and Explanatory Notes | Communication to industry, Retention Notifications | 12/05/2021 | 1 | Finance | pdf | Download | communication-to-industry retention-notifications | finance |
9.124 | Explanatory Note on Fees Payable for Technical Amendments Related to Quality | Communication to industry | 08/04/2021 | 2 | Finance | pdf | Download | communication-to-industry | finance |
| Annual retention fee payment notification for year ending 31 December 2024 | Communication to industry, Retention Notifications | 07/05/2024 | 1 | Finance | pdf | Download | communication-to-industry retention-notifications | finance |
| Annual retention fee payment notification for the Financial year ending 31 March 2020 | Communication to industry, Retention Notifications | 23/04/2021 | 1 | Finance | pdf | Download | communication-to-industry retention-notifications | finance |
| Annual retention fee payment notification for the Financial year ending 31 March 2022 | Communication to industry, Retention Notifications | 05/02/2021 | 1 | Finance | pdf | Download | communication-to-industry retention-notifications | finance |
CT01-2024/25 | South African Good Clinical Practice (GCP) Training Post Covid-19 Pandemic | Communication to industry | 29/04/2024 | 1 | Clinical Evaluations Management, Clinical Trials | pdf | Download | communication-to-industry | clinical-evaluations-management clinical-trials |
HPA-15 | Communication to Industry – Implementation of Regulatory Information Management System – Responses to queries in eSubmission format | Communication to industry | 29/04/2024 | 3 | General ECTD & human medicines, HPA | pdf | Download | communication-to-industry | general-ectd-human-medicines-guidelines hpa |
HPA-15 | Communication to Industry – Implementation of Regulatory Information Management System (RIMS) – Update on Progress | Communication to industry | 29/04/2024 | 2 | General ECTD & human medicines, HPA | pdf | Download | communication-to-industry | general-ectd-human-medicines-guidelines hpa |
PEM_Preg_01-2024/25 | EDQM CEP 2.0 Implementation | Communication to industry | 29/04/2024 | 1 | General ECTD & human medicines, PEM Pre-Reg, Pharmaceutical Evaluation Management | pdf | Download | communication-to-industry | general-ectd-human-medicines-guidelines pem-pre-reg pharmaceutical-evaluation-management |
| SAHPRA IB Sealing and Unsealing | Communication to industry | 11/04/2024 | 1 | Radiation Control, Radionuclides | pdf | Download | communication-to-industry | radiation-control radionuclides |
| Requests to use unregistered veterinary medicines under Section 21 of Act 101 of 1965 | Communication to industry | 22/03/2024 | 2 | Section 21, Unregistered products, Veterinary medicines | pdf | Download | communication-to-industry | section-21 unregistered-products veterinary-medicines |
FN01-2023/24 | Collection of Outstanding Retention Fees | Communication to industry, Retention Notifications | 08/03/2024 | 1 | Finance | pdf | Download | communication-to-industry retention-notifications | finance |
HPA-15 | Communication to Industry – Implementation of Regulatory Information Management System | Communication to industry | 06/03/2024 | 1 | General ECTD & human medicines, HPA | pdf | Download | communication-to-industry | general-ectd-human-medicines-guidelines hpa |
| Pharmacovigilance Process of Issuing Safety Recommendations to Applicants/HCRS For Implementation | Communication to industry | 29/02/2024 | 1 | Pharmacovigilance | pdf | Download | communication-to-industry | pharmacovigilance |
RN01-2023/24 | Minimum Requirements For Establishment of Internal Rules | Communication to industry | 29/02/2024 | 1 | Radiation Control, Radionuclides | pdf | Download | communication-to-industry | radiation-control radionuclides |
CT03-2023 | COVID-19 Clinical Trials – Two-Weekly Progress Reports | Communication to industry | 02/01/2024 | 1 | Clinical Evaluations Management, Clinical Trials | pdf | Download | communication-to-industry | clinical-evaluations-management clinical-trials |
| Clinical Trial Applications Electronic System | Communication to industry | 13/12/2023 | 1 | Clinical Evaluations Management, Clinical Trials | pdf | Download | communication-to-industry | clinical-evaluations-management clinical-trials |
| Cannabis Pre Licence Application Status Letter | Communication to industry | 19/02/2021 | 1 | Inspectorate and good manufacturing practices | pdf | Download | communication-to-industry | inspectorate-and-good-manufacturing-practices |
| Clinical Trials Committee and Submission Dates for 2024 | Communication to industry, Guideline | 12/10/2023 | 1 | Clinical Evaluations Management, Clinical Trials | pdf | Download | communication-to-industry guideline | clinical-evaluations-management clinical-trials |
MD038 | SAHPRA position on EU regulatory transition for medical devices from MDD/AIMDD/IVDD to MDR 2017/745 /IVDR 2017/746 | Communication to industry | 02/10/2023 | 1 | Medical Devices, Radiation Control | pdf | Download | communication-to-industry | medical-devices radiation-control |
| Process Flow of Importation of Medical Products Published | Communication to industry | 17/07/2023 | 1 | Inspectorate and good manufacturing practices, Regulatory Compliance | pdf | Download | communication-to-industry | inspectorate-and-good-manufacturing-practices regulatory-compliance |
HPA13 | Digital Variations Portal (DVP) User Changes | Communication to industry | 11/07/2023 | 1 | General ECTD & human medicines | pdf | Download | communication-to-industry | general-ectd-human-medicines-guidelines |
| Annual retention fee payment notification for the Financial year ending 31 December 2023 | Communication to industry, Retention Notifications | 08/06/2023 | 1 | Finance | pdf | Download | communication-to-industry retention-notifications | finance |
| B-BBEE Policy for Issuance of Licences as per Section 22c of the Medicines Act | Communication to industry | 23/06/2023 | 1 | Legal | pdf | Download | communication-to-industry | legal |
HPA-08 | FAQs on Medicine Registration Renewals | Communication to industry | 22/08/2023 | 5 | General ECTD & human medicines, HPA | pdf | Download | communication-to-industry | general-ectd-human-medicines-guidelines hpa |
| Communication to industry – SAHPRA Statement on Regulation of Category D Medicines | Communication to industry | 02/06/2023 | 1 | Complementary Medicines | pdf | Download | communication-to-industry | complementary-medicines |
HPA12 | Communication to Industry – Health Products Register Notification | Communication to industry | 31/05/2023 | 1 | HPA | pdf | Download | communication-to-industry | hpa |
PEM03-2022/23 | Implementation of the QOS and QIS | Communication to industry | 23/05/2023 | 1 | General ECTD & human medicines, PEM Pre-Reg, Pharmaceutical Evaluation Management | pdf | Download | communication-to-industry | general-ectd-human-medicines-guidelines pem-pre-reg pharmaceutical-evaluation-management |
HPA-11 | Communication on Hard Copy Registration Certificates | Communication to industry | 17/02/2023 | 1 | General ECTD & human medicines, HPA | pdf | Download | communication-to-industry | general-ectd-human-medicines-guidelines hpa |
| Verification of Fees and Bank details | Communication to industry | 22/02/2023 | 1 | Finance | pdf | Download | communication-to-industry | finance |
HPA-10 | Communication to Industry – Pilot Application Process through the SAHPRA Service Desk | Communication to industry | 01/02/2023 | 1 | General ECTD & human medicines, HPA | pdf | Download | communication-to-industry | general-ectd-human-medicines-guidelines hpa |
| Communication to Industry – Importing and operating unlicensed dental X-ray equipment | Communication to industry | 16/02/2023 | 1 | Radiation Control | pdf | Download | communication-to-industry | radiation-control |
HPA01-2022 | Medicines Registration Renewals Implementation Framework | Communication to industry | 31/07/2024 | 7 | General ECTD & human medicines | pdf | Download | communication-to-industry | general-ectd-human-medicines-guidelines |
HPA09 | Pre-registration veterinary medicines tracker guide | Communication to industry | 08/12/2022 | 1 | General ECTD & human medicines, Veterinary medicines | pdf | Download | communication-to-industry | general-ectd-human-medicines-guidelines veterinary-medicines |
| Certification Variation Screening – Type II Proprietary Name Change Applications and TOAs | Communication to industry | 14/12/2022 | 2 | General ECTD & human medicines | pdf | Download | communication-to-industry | general-ectd-human-medicines-guidelines |
| Expression of Interest-WHO Pre-Qualification Collaborative Registration Procedure | Communication to industry | 17/11/2022 | 1 | General ECTD & human medicines | pdf | Download | communication-to-industry | general-ectd-human-medicines-guidelines |
| Clinical Trials Committee And Submission Dates For 2023 | Communication to industry | 14/10/2022 | 1 | Clinical Evaluations Management, Clinical Trials | pdf | Download | communication-to-industry | clinical-evaluations-management clinical-trials |
HPA07 | Certification Variation Screening – Type II Proprietary name change applications and TOA’s | Communication to industry | 20/10/2022 | 1 | General ECTD & human medicines | pdf | Download | communication-to-industry | general-ectd-human-medicines-guidelines |
| Position Paper – Proposal to Applicants for Dossier Processing Fee (ZaZiBoNa) | Communication to industry | 13/10/2022 | 1 | General ECTD & human medicines | docx | Download | communication-to-industry | general-ectd-human-medicines-guidelines |
| Over-arching: Good Review Practice Guide | Communication to industry, Guide | 24/06/2022 | 1 | Corporate, General ECTD & human medicines | pdf | Download | communication-to-industry guide | corporate general-ectd-human-medicines-guidelines |
| Extension on commentary period for Borderline Products Guideline | Communication to industry | 15/09/2022 | 1 | Corporate, General ECTD & human medicines | pdf | Download | communication-to-industry | corporate general-ectd-human-medicines-guidelines |
MD037 | Withdrawal of Section 21 Authorisation for use of unregistered rapidly developed non-invasive ventilators | Communication to industry | 22/07/2022 | 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| Missing Applications – Call to Industry | Communication to industry | 18/08/2022 | 1 | Corporate, General ECTD & human medicines, Information Technology | pdf | Download | communication-to-industry | corporate general-ectd-human-medicines-guidelines information-technology |
| SAHPRA Digital Transformation – Deployment of a Stakeholder portal | Communication to industry | 17/08/2022 | 1 | Corporate, Information Technology | pdf | Download | communication-to-industry | corporate information-technology |
| Electronic Submission Of Adverse Drug Reaction (ADR) Reports – E2b Reporting | Communication to industry | 18/08/2022 | 1 | Pharmacovigilance | pdf | Download | communication-to-industry | pharmacovigilance |
| Expression Of Interest: SADC Medicines Regulatory Worksharing, Zazibona Collaborative Process | Communication to industry, Expression of interest | 24/10/2019 | 1 | General ECTD & human medicines | pdf | Download | communication-to-industry expression-of-interest | general-ectd-human-medicines-guidelines |
MD036 | COVID-19 Test Kits Batch Verification | Communication to industry | 16/06/2022 | 1 | Medical Devices | www | Download | communication-to-industry | medical-devices |
PEM01-2024/25 | Communication to Industry on Nitrosamine Review for New Applications and Registered Products including Biologicals | Communication to industry | 15/05/2024 | 2 | General ECTD & human medicines | pdf | Download | communication-to-industry | general-ectd-human-medicines-guidelines |
| Retention Fee Notification – 9 June 2022 | Communication to industry | 24/06/2022 | 1 | Biological Medicines, 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 to Industry – Applications for GMP and CPP Certificates | Communication to industry | 30/06/2022 | 1 | Inspectorate and good manufacturing practices | pdf | Download | communication-to-industry | inspectorate-and-good-manufacturing-practices |
| Payment of annual retention fees for registered products | Communication to industry | 25/05/2022 | 1 | General ECTD & human medicines | pdf | Download | communication-to-industry | general-ectd-human-medicines-guidelines |
MD033 | Specification criteria for COVID-19 rapid antigen selftests | Communication to industry | 18/03/2022 | 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| Conformity of assessment body DoC template | Communication to industry, Templates | 30/03/2022 | 1 | Medical Devices | docx | Download | communication-to-industry templates | medical-devices |
| Conformity assessment body(cab) requirements for recognition by Sahpra checklist | Checklist, Communication to industry | 24/03/2022 | 1 | Medical Devices | pdf | Download | checklist communication-to-industry | medical-devices |
MD035 | Usability studies for Covid-19 self-testing kits requirements | Communication to industry | 24/03/2022 | 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
MD034 | Conditions for use of COVID-19 antigen self-test kits | Communication to industry | 17/03/2022 | 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
MD032 | ISO 13485 Conformity Assessment Body Communication | Communication to industry | 19/08/2022 | 2 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| Communication to Stakeholders with regards to the current status of the Medical Device Regulations | Communication to industry | 23/03/2022 | 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| Upcoming SAHPRA and Industry workshop | Communication to industry | 17/03/2022 | 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| Submission of Post-Importation Testing Exemption requests for Biological and Biosimilar Medicines | Communication to industry | 24/03/2022 | 1 | Biological Medicines, Inspectorate and good manufacturing practices | pdf | Download | communication-to-industry | biological-medicines-evaluation-and-research inspectorate-and-good-manufacturing-practices |
7.04 | Communication to industry – 7.04 Health Supplements Safety and Efficacy | Communication to industry | 17/03/2022 | 1 | Complementary Medicines | pdf | Download | communication-to-industry | complementary-medicines |
| Requests: Existing Category D (Complementary Medicines) Registration Applications (07 October 2021) | Communication to industry | 17/02/2022 | 1 | Complementary Medicines | pdf | Download | communication-to-industry | complementary-medicines |
HPA03 | Priority Review Requests Communication | Communication to industry | 11/12/2023 | 3 | General ECTD & human medicines | pdf | Download | communication-to-industry | general-ectd-human-medicines-guidelines |
MD031 | Medical Device Establishment Licence Renewal Process | Communication to industry | 22/09/2022 | 2 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
MD030 | Medical Device Establishment Licence Renewal – ISO13485 Certificate Communication | Communication to industry | 02/02/2022 | 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
9.96 | Transitional Arrangements for Medical Devices | Communication to industry, Position statement | 27/04/2017 | 1 | Medical Devices | pdf | Download | communication-to-industry position-statement | medical-devices |
9.79 | Medical Device Establishments: License Requirements | Communication to industry, Position statement | 21/09/2016 | 1 | Medical Devices | pdf | Download | communication-to-industry position-statement | medical-devices |
9.78 | Disinfectants Status of Antiseptics and Germicides | Communication to industry, Position statement | 21/07/2016 | 1 | Medical Devices | pdf | Download | communication-to-industry position-statement | medical-devices |
9.106 | Class A Medical Devices | Communication to industry, Position statement | 14/09/2017 | 1 | Medical Devices | pdf | Download | communication-to-industry position-statement | medical-devices |
9.105 | Section 21 Authorisation of Sale Unregistered Medical Devices | Communication to industry, Position statement | 16/11/2017 | 1 | Emergency use, Medical Devices, Section 21, Unregistered products | pdf | Download | communication-to-industry position-statement | emergency-use medical-devices section-21 unregistered-products |
9.103 | Tissue Engineering Products | Communication to industry, Position statement | 16/11/2017 | 1 | Medical Devices | pdf | Download | communication-to-industry position-statement | medical-devices |
2.32 | Wound Dressings | Communication to industry, Position statement | 23/11/2011 | 1 | Medical Devices | pdf | Download | communication-to-industry position-statement | medical-devices |
| Reprocessing of Single Use Medical Devices Communication to Stakeholders | Communication to industry, Position statement | 20/11/2019 | 1 | Medical Devices | pdf | Download | communication-to-industry position-statement | medical-devices |
| Communication to Industry Licence Amendment | Communication to industry, Position statement | 27/11/2019 | 1 | Medical Devices | pdf | Download | communication-to-industry position-statement | medical-devices |
| Communication to Industry Licence Acknowledgement Letter | Communication to industry, Position statement | 28/11/2019 | 1 | Medical Devices | pdf | Download | communication-to-industry position-statement | medical-devices |
21.9 | Communication to industry on metformin-containing medicines | Communication to industry, Safety Alerts | 14/10/2020 | 1 | Pharmacovigilance | | Download | communication-to-industry safety-alerts | pharmacovigilance |
21.8 | Communication to industry on ranitidine-containing medicines | Communication to industry, Safety Alerts | 22/10/2020 | 1 | Pharmacovigilance | | Download | communication-to-industry safety-alerts | pharmacovigilance |
| Communication to industry on Post Marketing Reporting of ADRs guideline | Communication to industry | 31/05/2021 | 1 | Pharmacovigilance | pdf | Download | communication-to-industry | pharmacovigilance |
| SAHPRA survey to determine company turnover | Communication to industry | 31/03/2021 | 1 | Inspectorate and good manufacturing practices, Licencing | pdf | Download | communication-to-industry | inspectorate-and-good-manufacturing-practices licencing |
| GMP CERTIFICATES FOR CANNABIS CULTIVATED BY CULTIVATORS HOLDING A SECTION 22C(1)(b) LICENCE (LICENCE TO CULTIVATE CANNABIS FOR THE PURPOSES OF PRODUCING SCHEDULED SUBSTANCES) | Communication to industry | 25/03/2021 | 1 | Inspectorate and good manufacturing practices, Licencing | pdf | Download | communication-to-industry | inspectorate-and-good-manufacturing-practices licencing |
MD029 | Renewal of Section 21 Authorisation for use of unregistered rapidly developed non-invasive ventilators | Communication to industry | 24/06/2021 | 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
MD028 | Communication Retention Fees | Communication to industry | 27/05/2021 | 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
MD027 | Section 21 Authorisation for the Importation of Research Use Only (RUO) In Vitro Diagnostic Devices (IVDs) | Communication to industry | 12/03/2021 | 1 | Medical Devices | docx | Download | communication-to-industry | medical-devices |
MD025 | Alternative licensing and regulatory pathway for masks | Communication to industry | 24/09/2020 | 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
MD025 | Licensing and Regulatory requirements for the manufacture and distribution of medical and respirator masks during Covid-19 | Communication to industry | 22/09/2020 | 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
MD024 | Frequently asked questions: Performance evaluation of point-of-care COVID-19 serology antibody test kits | Communication to industry | 19/09/2020 | 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
MD022 | Application Clinical Evaluation Medical Device IVD | Communication to industry | 19/08/2020 | 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
MD021 | Use SARS CoV-2 Antibody Tests NDOH | Communication to industry | 13/08/2020 | 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
MD020 | Certificate of Free Sale | Communication to industry | 03/07/2020 | 2 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
MD019 | Processing of licence applications | Communication to industry | 16/07/2020 | 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
MD018 | Specifications Molecular Test kits | Communication to industry | 23/07/2020 | 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
MD017 | Technical Review Application COVID-19 Molecular Test | Communication to industry | 15/07/2020 | 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
MD016 | Conditions of Use COVID-19 Serological Test Kits | Communication to industry | 16/07/2020 | 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
MD015 | Process Flow Imported COVID-19 Test Kits | Communication to industry | 17/03/2022 | 2 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
MD014 | Regulatory Requirements for Molecular Test Kits | Communication to industry | 17/07/2020 | 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
MD013 | Process Flow Locally Manufactured COVID-19 Test Kits | Communication to industry | 17/07/2020 | 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
MD012 | Notice of Contravention of Act 101 of 1965 | Communication to industry | 31/07/2020 | 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
MD011 | Licence Conditions for COVID-19 Serological Test Kits | Communication to industry | 15/07/2020 | 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
MD009 | Alternative Regulatory Licensing Requirements Alcohol-based sanitisers | Communication to industry | 17/07/2020 | 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
MD008 | ISO Standards for Medical Devices and Protective Clothing | Communication to industry | 16/07/2020 | 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
MD007 | Specifications Serological Test kits | Communication to industry | 14/07/2020 | 2 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
MD006 | Laboratory Testing and Use of COVID-19 Serological Test Kits | Communication to industry | 09/07/2020 | 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
MD005 | Expedited Regulatory Pathways for Medical Devices | Communication to industry | 16/07/2020 | 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
MD003 | Testing for COVID-19 | Communication to industry | 09/07/2020 | 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
MD002 | Regulatory Requirements for Serological Test Kits | Communication to industry | 17/07/2020 | 2 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
MD001 | Regulatory Requirements for Medical Devices COVID-19 | Communication to industry | 16/07/2020 | 2 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| Communication to Stakeholders: Licensing of Complementary Medicines Manufacturers, Wholesalers, Distributors, Importers and Exporters | Communication to industry | 26/02/2020 | 1 | Complementary Medicines | pdf | Download | communication-to-industry | complementary-medicines |
| REQUESTS: Existing Category D (Complementary Medicines) Registration Applications – COMPLEMENTARY MEDICINES APPLICATIONS SUBMITTED FOR REGISTRATION | Communication to industry | 27/10/2021 | 1 | Complementary Medicines | pdf | Download | communication-to-industry | complementary-medicines |
| Review of detained product at a port of entry as a Category D medicine | Communication to industry | 30/11/2021 | 1 | Complementary Medicines | pdf | Download | communication-to-industry | complementary-medicines |
| Application for a certificate of free sale for Category D medicines (Complementary Medicines) | Communication to industry | 24/11/2021 | 1 | Complementary Medicines | pdf | Download | communication-to-industry | complementary-medicines |
7.02 | updated – Roadmap and transitional process for the Regulation of complementary medicines | Communication to industry | 08/12/2021 | 1 | Complementary Medicines | pdf | Download | communication-to-industry | complementary-medicines |
| Communication to industry on Clones and Replicas | Communication to industry | 26/11/2020 | 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 | 22/10/2020 | 1 | 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 | 21/10/2020 | 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 | 22/10/2020 | 2 | General ECTD & human medicines | pdf | 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 | 23/11/2021 | 1 | General ECTD & human medicines | pdf | Download | communication-to-industry | general-ectd-human-medicines-guidelines |
| Clinical Trials Committee and Submission dates for 2022 | Communication to industry | 24/06/2021 | 1 | Clinical Trials | pdf | Download | communication-to-industry | clinical-trials |
| Section 21 Access to Unregistered Medicines – IVERMECTIN CONTROLLED COMPASSIONATE USE PROGRAMME | Communication to industry, Guideline | 19/05/2022 | 2 | Emergency use, Section 21, Unregistered products | www | Download | communication-to-industry guideline | emergency-use section-21 unregistered-products |
MD010 | Guidance Rapidly developed ventilator | Communication to industry | 13/05/2020 | 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
MD004 | Extension – Use of acknowledgement letter in lieu of a licence | Communication to industry | 05/03/2020 | 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
9.129 | Re-submission of BAU New Medicines Applications from 2018 and 2019 | Communication to industry | 20/10/2021 | 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 | 21/07/2021 | 2 | General ECTD & human medicines | | Download | communication-to-industry | general-ectd-human-medicines-guidelines |
9.127 | eCTD Implementation roadmap communication | Communication to industry | 27/10/2021 | 2 | General ECTD & human medicines | | Download | communication-to-industry | general-ectd-human-medicines-guidelines |
SAHPGL-HPA-05 | BAU Variations Communication | Communication to industry | 07/09/2022 | 4 | General ECTD & human medicines, HPA | pdf | Download | communication-to-industry | general-ectd-human-medicines-guidelines hpa |
| Industry Communication on Interim Measures Pending Update of Variation Addendum | Communication to industry, Guideline | 10/09/2020 | 1 | General ECTD & human medicines | pdf | Download | communication-to-industry guideline | general-ectd-human-medicines-guidelines |
9.126 | Reflection document on regulatory requirements for vaccines intended to provide protection against variant strain(s) of SARS-CoV-2 | Communication to industry | 20/05/2021 | 1 | Biological Medicines | | Download | communication-to-industry | biological-medicines-evaluation-and-research |