Covid-19 | Subscribe

GENERAL, ECTD & HUMAN MEDICINES COMMUNICATION TO INDUSTRY

Document NumberTitleCategoriesDate UpdatedVersionUnitsFile TypeLinkdoc_categories_hfilterdoc_tags_hfilter
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
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
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
HPA-15Communication to Industry – Implementation of Regulatory Information Management System – Update on Progress28/05/20246, pdfDownloadcommunication-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, 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
HPA-15Communication to Industry – Implementation of Regulatory Information Management System06/03/20241, pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines hpa
HPA13Digital Variations Portal (DVP) User Changes11/07/20231pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
HPA-08FAQs on Medicine Registration Renewals22/08/20235, pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines hpa
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
HPA-10Communication to Industry – Pilot Application Process through the SAHPRA Service Desk01/02/20231, pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines hpa
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
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
Missing Applications – Call to Industry18/08/20221, , pdfDownloadcommunication-to-industrycorporate general-ectd-human-medicines-guidelines information-technology
Expression Of Interest: SADC Medicines Regulatory Worksharing, Zazibona Collaborative Process, 24/10/20191pdfDownloadcommunication-to-industry expression-of-interestgeneral-ectd-human-medicines-guidelines
PEM01-2024/25Communication to Industry on Nitrosamine Review for New Applications and Registered Products including Biologicals15/05/20242pdfDownloadcommunication-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
Payment of annual retention fees for registered products25/05/20221pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
HPA03Priority Review Requests Communication11/12/20233pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
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
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