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Document NumberTitleCategoriesDate UpdatedVersionUnitsFile TypeLinkdoc_categories_hfilterdoc_tags_hfilter
RC02-2024/2025Absence of Border Medicines Control Technicians at the Ports of Entry on 29 November 202425/11/20241, pdfDownloadcommunication-to-industryinspectorate-and-good-manufacturing-practices regulatory-compliance
FN02-2024/25Submission Dates for Claims22/11/20241pdfDownloadcommunication-to-industryfinance
PEM POST 04-2024/25Quality Variations11/11/20241, pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines pem-post-reg
HPA16-2024/25SAHPRA Engagement Portal07/11/20241, pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines hpa
HPA15-2024/25Implementation of Regulatory Information Management System – Information on eCTD 3.1 Module 1 – Document Matrix29/10/20248, pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines hpa
HPA15-2024/25Communication to Industry – Implementation of RIMS – Information on eCTD 3.1 Module 125/10/20247, pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines hpa
CT03-2024/25Clinical Trials Committee Meeting and Submission Dates for 202514/10/20241, pdfDownloadcommunication-to-industryclinical-evaluations-management clinical-trials
VET01-2024/25Communication to Industry – Request for Scientific Information on Yohimbine Use in Veterinary Medicine11/10/20241pdfDownloadcommunication-to-industryveterinary-medicines
CT02-2024/25Clinical Trial Applications – Investigational Product Import Licence25/09/20241, pdfDownloadcommunication-to-industryclinical-evaluations-management clinical-trials
Communication to Industry – Policy Position of SAHPRA on Enabling Local Manufacture17/09/20241pdfDownloadcommunication-to-industrycorporate
MD01-2023/24Mpox Diagnostic Tests13/09/20241pdfDownloadcommunication-to-industrymedical-devices
CLINPR02-2024/25Phenylephrine Lack of Effectiveness of Oral Preparations as Nasal Decongestant01/08/20241, pdfDownloadcommunication-to-industryclinical-evaluations-management general-ectd-human-medicines-guidelines
CLINPR01-2024/25Restriction on Codeine Use in Children, Pregnant and/or Breastfeeding Mothers01/08/20241, pdfDownloadcommunication-to-industryclinical-evaluations-management general-ectd-human-medicines-guidelines
PEM-POST-02-2024_25Communication to Industry – FAQs on Active Pharmaceutical Ingredient23/07/20241pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
PEM-POST-01-2024/25Frequently asked questions (FAQs) and common deficiencies for the submission of PEM Post-Registration variations, 23/07/20245, pdfDownloadcommunication-to-industry faqgeneral-ectd-human-medicines-guidelines pem-post-reg
B-BBEE Policy for Issuance of Licences – for further comments09/07/20242pdfDownloadcommunication-to-industrylegal
HPA-15Communication to Industry – Implementation of the Regulatory Information Management System, Version 5 Portal & Interim DVP use09/07/20245, pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines hpa
HPA-16ZA-SAHPRA CTD eSubmission Specification – Document for comment06/06/20243, pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines hpa
MD01-2024/2025Contact details for Guideline SAHPGL-MD-03 Medical Device Vigilance: Adverse Events Reporting for License Holders09/07/20241pdfDownloadcommunication-to-industrymedical-devices
HPA-15Communication to Industry – Implementation of Regulatory Information Management System – Update on Progress28/05/20246, pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines hpa
Expression of Interest for Medical Device Registration Voluntary Feasibility Study17/05/20241pdfDownloadcommunication-to-industrymedical-devices
RC02-2024/2025Physical Resubmission of Shipment Documentation for SAHPRA Review and Stamp16/05/20241, pdfDownloadcommunication-to-industryinspectorate-and-good-manufacturing-practices regulatory-compliance
RC01-2024/2025Delays in Shipment Release at OR Tambo International Airport10/05/20241, pdfDownloadcommunication-to-industryinspectorate-and-good-manufacturing-practices regulatory-compliance
Clinical Variations Fee Schedule and Explanatory Notes, 12/05/20211pdfDownloadcommunication-to-industry retention-notificationsfinance
9.124Explanatory Note on Fees Payable for Technical Amendments Related to Quality08/04/20212pdfDownloadcommunication-to-industryfinance
Annual retention fee payment notification for year ending 31 December 2024, 07/05/20241pdfDownloadcommunication-to-industry retention-notificationsfinance
Annual retention fee payment notification for the Financial year ending 31 March 2020, 23/04/20211pdfDownloadcommunication-to-industry retention-notificationsfinance
Annual retention fee payment notification for the Financial year ending 31 March 2022, 05/02/20211pdfDownloadcommunication-to-industry retention-notificationsfinance
CT01-2024/25South African Good Clinical Practice (GCP) Training Post Covid-19 Pandemic29/04/20241, pdfDownloadcommunication-to-industryclinical-evaluations-management clinical-trials
HPA-15Communication to Industry – Implementation of Regulatory Information Management System – Responses to queries in eSubmission format29/04/20243, pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines hpa
HPA-15Communication to Industry – Implementation of Regulatory Information Management System (RIMS) – Update on Progress29/04/20242, pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines hpa
PEM_Preg_01-2024/25EDQM CEP 2.0 Implementation29/04/20241, , pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines pem-pre-reg pharmaceutical-evaluation-management
SAHPRA IB Sealing and Unsealing11/04/20241, pdfDownloadcommunication-to-industryradiation-control radionuclides
Requests to use unregistered veterinary medicines under Section 21 of Act 101 of 196522/03/20242, , pdfDownloadcommunication-to-industrysection-21 unregistered-products veterinary-medicines
FN01-2023/24Collection of Outstanding Retention Fees, 08/03/20241pdfDownloadcommunication-to-industry retention-notificationsfinance
HPA-15Communication to Industry – Implementation of Regulatory Information Management System06/03/20241, pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines hpa
Pharmacovigilance Process of Issuing Safety Recommendations to Applicants/HCRS For Implementation29/02/20241pdfDownloadcommunication-to-industrypharmacovigilance
RN01-2023/24Minimum Requirements For Establishment of Internal Rules29/02/20241, pdfDownloadcommunication-to-industryradiation-control radionuclides
CT03-2023COVID-19 Clinical Trials – Two-Weekly Progress Reports02/01/20241, pdfDownloadcommunication-to-industryclinical-evaluations-management clinical-trials
Clinical Trial Applications Electronic System13/12/20231, pdfDownloadcommunication-to-industryclinical-evaluations-management clinical-trials
Cannabis Pre Licence Application Status Letter19/02/20211pdfDownloadcommunication-to-industryinspectorate-and-good-manufacturing-practices
Clinical Trials Committee and Submission Dates for 2024, 12/10/20231, pdfDownloadcommunication-to-industry guidelineclinical-evaluations-management clinical-trials
MD038SAHPRA position on EU regulatory transition for medical devices from MDD/AIMDD/IVDD to MDR 2017/745 /IVDR 2017/74602/10/20231, pdfDownloadcommunication-to-industrymedical-devices radiation-control
Process Flow of Importation of Medical Products Published17/07/20231, pdfDownloadcommunication-to-industryinspectorate-and-good-manufacturing-practices regulatory-compliance
HPA13Digital Variations Portal (DVP) User Changes11/07/20231pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
Annual retention fee payment notification for the Financial year ending 31 December 2023, 08/06/20231pdfDownloadcommunication-to-industry retention-notificationsfinance
B-BBEE Policy for Issuance of Licences as per Section 22c of the Medicines Act23/06/20231pdfDownloadcommunication-to-industrylegal
HPA-08FAQs on Medicine Registration Renewals22/08/20235, pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines hpa
Communication to industry – SAHPRA Statement on Regulation of Category D Medicines02/06/20231pdfDownloadcommunication-to-industrycomplementary-medicines
HPA12Communication to Industry – Health Products Register Notification31/05/20231pdfDownloadcommunication-to-industryhpa
PEM03-2022/23Implementation of the QOS and QIS23/05/20231, , pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines pem-pre-reg pharmaceutical-evaluation-management
HPA-11Communication on Hard Copy Registration Certificates17/02/20231, pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines hpa
Verification of Fees and Bank details22/02/20231pdfDownloadcommunication-to-industryfinance
HPA-10Communication to Industry – Pilot Application Process through the SAHPRA Service Desk01/02/20231, pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines hpa
Communication to Industry – Importing and operating unlicensed dental X-ray equipment16/02/20231pdfDownloadcommunication-to-industryradiation-control
HPA01-2022Medicines Registration Renewals Implementation Framework31/07/20247pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
HPA09Pre-registration veterinary medicines tracker guide08/12/20221, pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines veterinary-medicines
Certification Variation Screening – Type II Proprietary Name Change Applications and TOAs14/12/20222pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
Expression of Interest-WHO Pre-Qualification Collaborative Registration Procedure17/11/20221pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
Clinical Trials Committee And Submission Dates For 202314/10/20221, pdfDownloadcommunication-to-industryclinical-evaluations-management clinical-trials
HPA07Certification Variation Screening – Type II Proprietary name change applications and TOA’s20/10/20221pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
Position Paper – Proposal to Applicants for Dossier Processing Fee (ZaZiBoNa)13/10/20221docxDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
Over-arching: Good Review Practice Guide, 24/06/20221, pdfDownloadcommunication-to-industry guidecorporate general-ectd-human-medicines-guidelines
Extension on commentary period for Borderline Products Guideline15/09/20221, pdfDownloadcommunication-to-industrycorporate general-ectd-human-medicines-guidelines
MD037Withdrawal of Section 21 Authorisation for use of unregistered rapidly developed non-invasive ventilators22/07/20221pdfDownloadcommunication-to-industrymedical-devices
Missing Applications – Call to Industry18/08/20221, , pdfDownloadcommunication-to-industrycorporate general-ectd-human-medicines-guidelines information-technology
SAHPRA Digital Transformation – Deployment of a Stakeholder portal17/08/20221, pdfDownloadcommunication-to-industrycorporate information-technology
Electronic Submission Of Adverse Drug Reaction (ADR) Reports – E2b Reporting18/08/20221pdfDownloadcommunication-to-industrypharmacovigilance
Expression Of Interest: SADC Medicines Regulatory Worksharing, Zazibona Collaborative Process, 24/10/20191pdfDownloadcommunication-to-industry expression-of-interestgeneral-ectd-human-medicines-guidelines
MD036COVID-19 Test Kits Batch Verification16/06/20221wwwDownloadcommunication-to-industrymedical-devices
PEM01-2024/25Communication to Industry on Nitrosamine Review for New Applications and Registered Products including Biologicals15/05/20242pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
Retention Fee Notification – 9 June 202224/06/20221, , , pdfDownloadcommunication-to-industrybiological-medicines-evaluation-and-research general-ectd-human-medicines-guidelines inspectorate-and-good-manufacturing-practices medical-devices
Communication to Industry – Applications for GMP and CPP Certificates30/06/20221pdfDownloadcommunication-to-industryinspectorate-and-good-manufacturing-practices
Payment of annual retention fees for registered products25/05/20221pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
MD033Specification criteria for COVID-19 rapid antigen selftests18/03/20221pdfDownloadcommunication-to-industrymedical-devices
Conformity of assessment body DoC template, 30/03/20221docxDownloadcommunication-to-industry templatesmedical-devices
Conformity assessment body(cab) requirements for recognition by Sahpra checklist, 24/03/20221pdfDownloadchecklist communication-to-industrymedical-devices
MD035Usability studies for Covid-19 self-testing kits requirements24/03/20221pdfDownloadcommunication-to-industrymedical-devices
MD034Conditions for use of COVID-19 antigen self-test kits17/03/20221pdfDownloadcommunication-to-industrymedical-devices
MD032ISO 13485 Conformity Assessment Body Communication19/08/20222pdfDownloadcommunication-to-industrymedical-devices
Communication to Stakeholders with regards to the current status of the Medical Device Regulations23/03/20221pdfDownloadcommunication-to-industrymedical-devices
Upcoming SAHPRA and Industry workshop17/03/20221pdfDownloadcommunication-to-industrymedical-devices
Submission of Post-Importation Testing Exemption requests for Biological and Biosimilar Medicines24/03/20221, pdfDownloadcommunication-to-industrybiological-medicines-evaluation-and-research inspectorate-and-good-manufacturing-practices
7.04Communication to industry – 7.04 Health Supplements Safety and Efficacy17/03/20221pdfDownloadcommunication-to-industrycomplementary-medicines
Requests: Existing Category D (Complementary Medicines) Registration Applications (07 October 2021)17/02/20221pdfDownloadcommunication-to-industrycomplementary-medicines
HPA03Priority Review Requests Communication11/12/20233pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
MD031Medical Device Establishment Licence Renewal Process22/09/20222pdfDownloadcommunication-to-industrymedical-devices
MD030Medical Device Establishment Licence Renewal – ISO13485 Certificate Communication02/02/20221pdfDownloadcommunication-to-industrymedical-devices
9.96Transitional Arrangements for Medical Devices, 27/04/20171pdfDownloadcommunication-to-industry position-statementmedical-devices
9.79Medical Device Establishments: License Requirements, 21/09/20161pdfDownloadcommunication-to-industry position-statementmedical-devices
9.78Disinfectants Status of Antiseptics and Germicides, 21/07/20161pdfDownloadcommunication-to-industry position-statementmedical-devices
9.106Class A Medical Devices, 14/09/20171pdfDownloadcommunication-to-industry position-statementmedical-devices
9.105Section 21 Authorisation of Sale Unregistered Medical Devices, 16/11/20171, , , pdfDownloadcommunication-to-industry position-statementemergency-use medical-devices section-21 unregistered-products
9.103Tissue Engineering Products, 16/11/20171pdfDownloadcommunication-to-industry position-statementmedical-devices
2.32Wound Dressings, 23/11/20111pdfDownloadcommunication-to-industry position-statementmedical-devices
Reprocessing of Single Use Medical Devices Communication to Stakeholders, 20/11/20191pdfDownloadcommunication-to-industry position-statementmedical-devices
Communication to Industry Licence Amendment, 27/11/20191pdfDownloadcommunication-to-industry position-statementmedical-devices
Communication to Industry Licence Acknowledgement Letter, 28/11/20191pdfDownloadcommunication-to-industry position-statementmedical-devices
21.9Communication to industry on metformin-containing medicines, 14/10/20201Downloadcommunication-to-industry safety-alertspharmacovigilance
21.8Communication to industry on ranitidine-containing medicines, 22/10/20201Downloadcommunication-to-industry safety-alertspharmacovigilance
Communication to industry on Post Marketing Reporting of ADRs guideline31/05/20211pdfDownloadcommunication-to-industrypharmacovigilance
SAHPRA survey to determine company turnover31/03/20211, pdfDownloadcommunication-to-industryinspectorate-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)25/03/20211, pdfDownloadcommunication-to-industryinspectorate-and-good-manufacturing-practices licencing
MD029Renewal of Section 21 Authorisation for use of unregistered rapidly developed non-invasive ventilators24/06/20211pdfDownloadcommunication-to-industrymedical-devices
MD028Communication Retention Fees27/05/20211pdfDownloadcommunication-to-industrymedical-devices
MD027Section 21 Authorisation for the Importation of Research Use Only (RUO) In Vitro Diagnostic Devices (IVDs)12/03/20211docxDownloadcommunication-to-industrymedical-devices
MD025Alternative licensing and regulatory pathway for masks24/09/20201pdfDownloadcommunication-to-industrymedical-devices
MD025Licensing and Regulatory requirements for the manufacture and distribution of medical and respirator masks during Covid-1922/09/20201pdfDownloadcommunication-to-industrymedical-devices
MD024Frequently asked questions: Performance evaluation of point-of-care COVID-19 serology antibody test kits19/09/20201pdfDownloadcommunication-to-industrymedical-devices
MD022Application Clinical Evaluation Medical Device IVD19/08/20201pdfDownloadcommunication-to-industrymedical-devices
MD021Use SARS CoV-2 Antibody Tests NDOH13/08/20201pdfDownloadcommunication-to-industrymedical-devices
MD020Certificate of Free Sale03/07/20202pdfDownloadcommunication-to-industrymedical-devices
MD019Processing of licence applications16/07/20201pdfDownloadcommunication-to-industrymedical-devices
MD018Specifications Molecular Test kits23/07/20201pdfDownloadcommunication-to-industrymedical-devices
MD017Technical Review Application COVID-19 Molecular Test15/07/20201pdfDownloadcommunication-to-industrymedical-devices
MD016Conditions of Use COVID-19 Serological Test Kits16/07/20201pdfDownloadcommunication-to-industrymedical-devices
MD015Process Flow Imported COVID-19 Test Kits17/03/20222pdfDownloadcommunication-to-industrymedical-devices
MD014Regulatory Requirements for Molecular Test Kits17/07/20201pdfDownloadcommunication-to-industrymedical-devices
MD013Process Flow Locally Manufactured COVID-19 Test Kits17/07/20201pdfDownloadcommunication-to-industrymedical-devices
MD012Notice of Contravention of Act 101 of 196531/07/20201pdfDownloadcommunication-to-industrymedical-devices
MD011Licence Conditions for COVID-19 Serological Test Kits15/07/20201pdfDownloadcommunication-to-industrymedical-devices
MD009Alternative Regulatory Licensing Requirements Alcohol-based sanitisers17/07/20201pdfDownloadcommunication-to-industrymedical-devices
MD008ISO Standards for Medical Devices and Protective Clothing16/07/20201pdfDownloadcommunication-to-industrymedical-devices
MD007Specifications Serological Test kits14/07/20202pdfDownloadcommunication-to-industrymedical-devices
MD006Laboratory Testing and Use of COVID-19 Serological Test Kits09/07/20201pdfDownloadcommunication-to-industrymedical-devices
MD005Expedited Regulatory Pathways for Medical Devices16/07/20201pdfDownloadcommunication-to-industrymedical-devices
MD003Testing for COVID-1909/07/20201pdfDownloadcommunication-to-industrymedical-devices
MD002Regulatory Requirements for Serological Test Kits17/07/20202pdfDownloadcommunication-to-industrymedical-devices
MD001Regulatory Requirements for Medical Devices COVID-1916/07/20202pdfDownloadcommunication-to-industrymedical-devices
Communication to Stakeholders: Licensing of Complementary Medicines Manufacturers, Wholesalers, Distributors, Importers and Exporters26/02/20201pdfDownloadcommunication-to-industrycomplementary-medicines
REQUESTS: Existing Category D (Complementary Medicines) Registration Applications – COMPLEMENTARY MEDICINES APPLICATIONS SUBMITTED FOR REGISTRATION27/10/20211pdfDownloadcommunication-to-industrycomplementary-medicines
Review of detained product at a port of entry as a Category D medicine30/11/20211pdfDownloadcommunication-to-industrycomplementary-medicines
Application for a certificate of free sale for Category D medicines (Complementary Medicines)24/11/20211pdfDownloadcommunication-to-industrycomplementary-medicines
7.02updated – Roadmap and transitional process for the Regulation of complementary medicines08/12/20211pdfDownloadcommunication-to-industrycomplementary-medicines
Communication to industry on Clones and Replicas26/11/20201pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
2.19Communication to industry on metformin-containing medicines22/10/20201pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
2.18Communication to industry on ranitidine-containing medicines21/10/20201pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
2.17Communication to industry on the sartans-containing medicines22/10/20202pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
SAHPRA INVOLVEMENT IN THE SWISSMEDIC MARKETING AUTHORISATION FOR GLOBAL HEALTH PRODUCTS (MAGHP) PROCEDURE23/11/20211pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
Clinical Trials Committee and Submission dates for 202224/06/20211pdfDownloadcommunication-to-industryclinical-trials
Section 21 Access to Unregistered Medicines – IVERMECTIN CONTROLLED COMPASSIONATE USE PROGRAMME, 19/05/20222, , wwwDownloadcommunication-to-industry guidelineemergency-use section-21 unregistered-products
MD010Guidance Rapidly developed ventilator13/05/20201pdfDownloadcommunication-to-industrymedical-devices
MD004Extension – Use of acknowledgement letter in lieu of a licence05/03/20201pdfDownloadcommunication-to-industrymedical-devices
9.129Re-submission of BAU New Medicines Applications from 2018 and 201920/10/20212Downloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
9.128Pilot: BAU new medicine applications for registration21/07/20212Downloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
9.127eCTD Implementation roadmap communication27/10/20212Downloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
SAHPGL-HPA-05BAU Variations Communication07/09/20224, pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines hpa
Industry Communication on Interim Measures Pending Update of Variation Addendum, 10/09/20201pdfDownloadcommunication-to-industry guidelinegeneral-ectd-human-medicines-guidelines
9.126Reflection document on regulatory requirements for vaccines intended to provide protection against variant strain(s) of SARS-CoV-220/05/20211Downloadcommunication-to-industrybiological-medicines-evaluation-and-research