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Regulatory Information Management System (RIMS) – Technical Files

Home >  Regulatory Information Management System (RIMS) – Technical Files

23 Jul

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. ...

17 Jul

Posted at 13:15h in

The Medicines and Related Substances Act 101 of 1965, as amended, read together with the Regulations related to Medical Devices and IVDs, provides for the regulatory oversight of Medical Devices, including In Vitro Diagnostics (IVDs) in South Africa. In terms of Section 22C(1)(b) of the...

15 Jul

Posted at 14:05h in

This study investigates the utility of the Universal Methodology for Benefit-Risk Assessment (UMBRA) framework within the South African Health Products Regulatory Authority (SAHPRA) to determine whether adopting a structured approach improves consistency, transparency, and quality in benefit-risk assessments of new chemical entities (NCEs). The UMBRA...

14 Jul

Posted at 20:56h in

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...

30 Jun

Posted at 16:13h in

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...