This study co-authored by CIRS, the African Medicines Agency (AMA), and University of Hertfordshire, provides the first empirical evaluation of a continental centralised procedure for the scientific assessment and [...]
Update: 4 November 2026 | 10 country profiles now available The report has been updated to include individual country profiles, providing further detail on the implementation of regulatory reliance [...]
Watch Webinar Recording Join us for a webinar on regulatory reliance on Tuesday 30 June 9 AM Mexico 10 AM Colombia, Ecuador, Peru, EST 11am Chile 12 PM Argentina, [...]
The WHO Good Reliance Practices (Annex 10) provide essential principles and considerations for regulatory reliance implementation. However, it is not clear how well agencies have been incorporating these principles [...]
This CIRS multi-stakeholder workshop examined success factors for strengthening regulatory systems to support the implementation of collaborative models.
Introduction National regulatory medicines authorities (NRAs) are mandated to ensure timely access to high-quality, safe and efficacious medical products, primarily achieved through a marketing authorisation procedure established in each [...]
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 [...]
This CIRS multi-stakeholder workshop examined success factors for strengthening regulatory systems to support the implementation of collaborative models.
In this workshop, CIRS brought together senior representatives from regulators, HTA agencies, pharmaceutical companies, payers, academics and patient organisations to discuss the impact of regulatory and HTA collaborative models [...]
Background and Objectives The inherited backlog of 16,000 medicines applications of the South African Health Products Regulatory Authority (SAHPRA) was cleared through facilitated review pathways that included reliance on [...]
