How effectively are regulatory authorities in Latin America implementing regulatory reliance in practice? This report presents findings from the first phase of a CIRS research project, showing that 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 [...]
Background In 2012, the East African Community Medicines Regulatory Harmonization (EAC-MRH) initiative was established to improve access to safe, effective, and high-quality medical products to patients in the East [...]
