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Industry Webinar | Updates on Regulatory Information Management (RIMS) Roll-Out
March 14 @ 11:00 am - 1:00 pm
The South African Health Products Regulatory Authority (SAHPRA) is hosting an Industry webinar for updates on the Regulatory Information Management System (RIMS) roll-out.
What to expect?
- SAHPRA will start with cut-over activities during the course of March 2024 and the implementation process on 02 April 2024. We have modernised the eCTD Guideline and have introduced a new flexible management structure to allow SAHPRA to add new submission types more easily in future and also manage the validation of submissions a lot easier.
- As part of the RIMS implementation, all eCTD applications (New applications, Renewal Applications and Variation applications – Type Ia, Ib and II) will be managed in the docuBridge environment and will be subject to the eCTD guidelines and requirements accordingly. From April to 30 June 2024, there is an interim requirement for a simple XML file to be included along with the eCTD dossier once loaded onto sFTP. We will go through the XML file requirements and duly share a “How-To” document and the simple template on the new Electronic Submissions Landing page.
- SAHPRA will also take the attendees through the roadmap for activities planned with the specific milestones for April 2024, July 2024 and October 2024.
We will have a high-level discussion around the custom-developed Portal and also discuss the process we will be running to invite a limited number of Industry users to participate in the Focus Group testing, along with internal users in May 2024, June 2024 and September 2024 for the Portal Phase I test and feedback discussions.
Who should attend?
It is quite important for the Industry users who will be preparing the submissions for Orthodox medicines and Biological medicines to attend this session to be apprised of the specifications guideline updates and linked changes and also where to find the relevant documents of matrix links.
A similar Update session will be held once the eSubmission specifications and guidelines are ready – which tentatively will be held in July 2024.
We want this webinar to be interactive and engaging – so be sure to ask questions during the session through the chat interface.
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Please note that we are unable to provide the video recording due the global outage of MS Office 365 that affected the recording of the Teams Meeting. However, please have a look at the presentation from our COO, Christelna Reynecke on the South African eCTD 3.0 Launch – 14 March 2024.