SAHPRA wishes to inform you of a fee discrepancy identified on the SAHPRA Engagement Portal affecting the following submission types:...
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. Regarding Category D medicines, the guidance provided herein pertains to general content requirements. Any specific technical guidance indicated in...
This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration, as well as variations, of medicines in eCTD format. It reflects the current situation and will be regularly updated with changes in legislation and experience gained. It is important...
Dear Applicants, This roadmap outlines the phased implementation of unique product identification requirements for all health products in South Africa, transitioning from batch-level to unit-level serialisation across primary, secondary, and tertiary packaging levels....
The checklist must be used by the applicant for all new product submissions for human medicines only from 01 October 2025. This template shall be used on receipt of a new human medicine application for registration to verify that all the required information for evaluation has...
This document outlines the approach that the South African Health Products Regulatory Authority (SAHPRA) has undertaken to implement the process of the renewal of the certificate of registration for medicinal products, ensuring a consistent approach to benefit all stakeholders, thereby guaranteeing that quality, efficacious, and...
Dear Applicants, Following the communication and internal engagement on the interpretation of the Fees Gazette for Variation fees, the South African Health Products Regulatory Authority (SAHPRA) will apply the following calculation approach on fees to allow the new fee gazette to then adequately granulate the position...
The South African Health Products Regulatory Authority (SAHPRA) has released key updates affecting technical files within the SAHPRA eCTD repository, accessible via the following location: SAHPRA eCTD. These updates include: A revision to the Submissions Type Matrix, aligned with the new portal restrictions on variations groupings. ...
Dear Applicants, As we progress with the South African Health Products Regulatory Authority (SAHPRA) Portal implementation – we note several enquiries submitted by organisations as individual emails and escalated one by one. This unfortunate tactic has now severely bottlenecked the support desk email address, and applicants who have been...
Normal submission of Type IA & IAIN, IB, II The South African Health Products Regulatory Authority (SAHPRA) allows for variation submissions as follows: Type IA variations (inclusive of Type IAIN): a maximum of three (3) type IA variation changes (unrelated or related) is applicable for a...
