General ECTD & human medicines Archives - Page 12 of 23

06 Feb African Medicines Agency (AMA) Continental Listing Procedure

Posted at 09:13h in

SAHPRA is committed to supporting regulatory convergence and harmonisation initiatives across the African continent to enhance timely access to quality, safe, and effective health products. In alignment with this goal, SAHPRA has implemented a reliance pathway utilising assessments conducted under the African Medicines Agency (AMA)...

29 Jan SAHPRA Engagement Portal – Type II Pilot Variation Applications: Submission Window and Fee Processing Clarification

Posted at 15:23h in

The South African Health Products Regulatory Authority (SAHPRA) refers to Type II variation applications submitted under the Type II Pilot Programme and acknowledges the challenges experienced by certain applicants in finalising payment due to the different pricing calculation method applied through the Portal, as per...

18 Dec Variations Communication

Posted at 08:27h in

With reference to the communication issued on 30 June 2025 (HPA05-2025/26, Version 5), SAHPRA wishes to inform all holders of certificates of registration that the current predefined submission window for Type II variation applications (including related changes bundled variation submissions) within the period 02 January...

10 Dec SAHPRA Engagement Portal – Launch Update

Posted at 12:52h in

SAHPRA wishes to inform you of a fee discrepancy identified on the SAHPRA Engagement Portal affecting the following submission types:...

31 Oct Guideline for Labelling of Medicines Intended for Human Use

Posted at 14:48h in

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...

09 Oct SAHPRA ECTD Specification 3.1 and Guidance for Module 1 and Regional Information

Posted at 18:02h 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...

01 Oct Traceability Guideline – Implementation Roadmap

Posted at 14:35h in

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....

26 Aug Medicines Certificate of Registration Renewal Implementation Framework

Posted at 14:24h in

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...

06 Aug Communication to Industry | SAHPRA Engagement Portal – Launch Update [August]

Posted at 14:45h in

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...

23 Jul Regulatory Information Management System (RIMS) – Technical Files

Posted at 09:55h in

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. ...

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