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GENERAL, ECTD & HUMAN MEDICINES COMMUNICATION TO INDUSTRY

Document NumberTitleCategoriesDate UpdatedVersionUnitsLinkdoc_categories_hfilterdoc_tags_hfilter
HPA16-2025/26Traceability Guideline – Implementation Roadmap01/10/20251, , Downloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines hpa regulatory-compliance
HPA-RNW01-2025/26Medicines Certificate of Registration Renewal Implementation Framework26/08/20251, Downloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines hpa
HPA16-2025/26Communication to Industry | SAHPRA Engagement Portal – Launch Update [August]06/08/202515, Downloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines hpa
HPA16-2025/26Regulatory Information Management System (RIMS) – Technical Files18/07/202514, Downloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines hpa
HPA16-2025/26Communication to Industry – SAHPRA Engagement Portal – Launch Updates (14 July)14/07/202509, Downloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines hpa
HPA05-2025/26Communication to Industry – Variations Communication30/06/20255, Downloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines hpa
HPA15-2025/26Regulatory Information Management System – Technical Files – Website Upload13/06/202513, Downloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines hpa
HPA16-2025/26SAHPRA Engagement Portal – Launch Update04/06/20258, Downloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines hpa
HPA16-2025/26SAHPRA Engagement Portal – Variation, Renewal and Response Applications05/05/20257, Downloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines hpa
HPA16-2025/26SAHPRA Engagement Portal – Important Updates30/04/20256, Downloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines hpa
PEM01-2025 | CEM01-2025Bioequivalence studies performed by Contract Research Organisation (Synapse Labs Pvt. Ltd)29/04/20251, , , Downloadcommunication-to-industrycem general-ectd-human-medicines-guidelines pem-pre-reg pharmaceutical-evaluation-management
HPA16-2025/26SAHPRA Engagement Portal – Emergency Webinars04/04/20255, Downloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines hpa
HPA16-2025/26SAHPRA Engagement Portal – Locating Legacy Applications01/04/20254, Downloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines hpa
HPA16-2025/26SAHPRA Engagement Portal – Launch Update01/04/20253, Downloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines hpa
HPA16-2025/26SAHPRA Engagement Portal – Application IDs01/04/20252, Downloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines hpa
HPA15-2025/26Regulatory Information Management System – Cancellation of Health Product Registrations for non-eCTDs12/03/202512, Downloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines hpa
PEM01-2025 | CEM01-2025Comm Issue No.PEM01-CEM01-2025 – Bioequivalence studies performed by Contract Research Organisation (Synapse Labs Pvt. Ltd)10/03/20251, , , Downloadcommunication-to-industrycem clinical-evaluations-management general-ectd-human-medicines-guidelines pem
HPA15-2025/26Implementation of the Regulatory Information Management System– Status updates on the SAHPRA Engagement Portal27/02/202511, Downloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines hpa
HPA-RNW01-2024/25Fee Schedule and Explanatory Notes – Renewal of the Certificate of Registration19/02/20251, Downloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines hpa
HPA15-2025/26Communication to Industry – Implementation of RIMS – Information on eCTD 3.1 Module 1 – Document Matrix30/01/202510, Downloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines hpa
CLINPR03-2024/25Update: Phenylephrine – Lack of Effectiveness of Oral Preparations as Nasal Decongestant28/01/20251, Downloadcommunication-to-industryclinical-evaluations-management general-ectd-human-medicines-guidelines
HPA15-2025/26Regulatory Information Management System – Application Withdrawal22/01/20259, Downloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines hpa
PEM POST 04-2024/25Quality Variations11/11/20241, Downloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines pem-post-reg
HPA16-2024/25SAHPRA Engagement Portal07/11/20241, Downloadcommunication-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, Downloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines hpa
HPA15-2024/25Communication to Industry – Implementation of RIMS – Information on eCTD 3.1 Module 125/10/20247, Downloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines hpa
CLINPR02-2024/25Phenylephrine Lack of Effectiveness of Oral Preparations as Nasal Decongestant01/08/20241, Downloadcommunication-to-industryclinical-evaluations-management general-ectd-human-medicines-guidelines
CLINPR01-2024/25Restriction on Codeine Use in Children, Pregnant and/or Breastfeeding Mothers01/08/20241, Downloadcommunication-to-industryclinical-evaluations-management general-ectd-human-medicines-guidelines
PEM-POST-02-2024_25Communication to Industry – FAQs on Active Pharmaceutical Ingredient23/07/20241Downloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
PEM-POST-05-2024/25Frequently asked questions (FAQs) and common deficiencies for the submission of PEM Post-Registration variations, 07/03/20255, Downloadcommunication-to-industry faqgeneral-ectd-human-medicines-guidelines pem-post-reg
HPA-15Communication to Industry – Implementation of the Regulatory Information Management System, Version 5 Portal & Interim DVP use09/07/20245, Downloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines hpa
HPA-16ZA-SAHPRA CTD eSubmission Specification – Document for comment06/06/20243, Downloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines hpa
HPA-15Communication to Industry – Implementation of Regulatory Information Management System – Update on Progress28/05/20246, Downloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines hpa
HPA-15Communication to Industry – Implementation of Regulatory Information Management System – Responses to queries in eSubmission format29/04/20243, Downloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines hpa
HPA-15Communication to Industry – Implementation of Regulatory Information Management System (RIMS) – Update on Progress29/04/20242, Downloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines hpa
PEM_Preg_01-2024/25EDQM CEP 2.0 Implementation29/04/20241, , Downloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines pem-pre-reg pharmaceutical-evaluation-management
HPA-15Communication to Industry – Implementation of Regulatory Information Management System06/03/20241, Downloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines hpa
HPA13Digital Variations Portal (DVP) User Changes11/07/20231Downloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
PEM03-2022/23Implementation of the QOS and QIS23/05/20231, , Downloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines pem-pre-reg pharmaceutical-evaluation-management
HPA-11Communication on Hard Copy Registration Certificates17/02/20231, Downloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines hpa
HPA-10Communication to Industry – Pilot Application Process through the SAHPRA Service Desk01/02/20231, Downloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines hpa
HPA09Pre-registration veterinary medicines tracker guide08/12/20221, Downloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines veterinary-medicines
Certification Variation Screening – Type II Proprietary Name Change Applications and TOAs14/12/20222Downloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
HPA07Certification Variation Screening – Type II Proprietary name change applications and TOA’s20/10/20221Downloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
Position Paper – Proposal to Applicants for Dossier Processing Fee (ZaZiBoNa)13/10/20221Downloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
Over-arching: Good Review Practice Guide, 24/06/20221, Downloadcommunication-to-industry guidecorporate general-ectd-human-medicines-guidelines
Extension on commentary period for Borderline Products Guideline15/09/20221, Downloadcommunication-to-industrycorporate general-ectd-human-medicines-guidelines
Missing Applications – Call to Industry18/08/20221, , Downloadcommunication-to-industrycorporate general-ectd-human-medicines-guidelines information-technology
Expression Of Interest: SADC Medicines Regulatory Worksharing, Zazibona Collaborative Process, 24/10/20191Downloadcommunication-to-industry expression-of-interestgeneral-ectd-human-medicines-guidelines
PEM01-2024/25Communication to Industry on Nitrosamine Review for New Applications and Registered Products including Biologicals15/05/20242Downloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
Retention Fee Notification – 9 June 202224/06/20221, , , Downloadcommunication-to-industrybiological-medicines-evaluation-and-research general-ectd-human-medicines-guidelines inspectorate-and-good-manufacturing-practices medical-devices
Payment of annual retention fees for registered products25/05/20221Downloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
HPA03Priority Review Requests Communication11/12/20233Downloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
Communication to industry on Clones and Replicas26/11/20201Downloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
2.19Communication to industry on metformin-containing medicines22/10/20201Downloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
2.18Communication to industry on ranitidine-containing medicines21/10/20201Downloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
2.17Communication to industry on the sartans-containing medicines22/10/20202Downloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
SAHPRA INVOLVEMENT IN THE SWISSMEDIC MARKETING AUTHORISATION FOR GLOBAL HEALTH PRODUCTS (MAGHP) PROCEDURE23/11/20211Downloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
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, Downloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines hpa
Industry Communication on Interim Measures Pending Update of Variation Addendum, 10/09/20201Downloadcommunication-to-industry guidelinegeneral-ectd-human-medicines-guidelines