Regulatory Information Management System (RIMS) – Technical Files

Regulatory Information Management System (RIMS) – Technical Files

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.
  • Enhanced stylesheets for both the Document Matrix and the Submissions Type Matrix, offering improved navigation and usability.
Download latest version
Document Number: HPA16-2025/26
Version: 14
Date Updated: 18/07/2025
File Type: pdf
Category: Communication to industry
Unit: General ECTD & human medicines, HPA