Introduction: National medicines regulatory agencies are faced with challenges including limited resources and technical capacity, resulting in countries collaborating and sharing resources to improve efficiency of the review process to [...]
Background: This study was built on the previous 2018/2019 assessment where ICH selected the Centre for Innovation in Regulatory Science (CIRS) to collaborate on the development and the conduct [...]
Background: The aims of this study were to compare the overall regulatory review timelines achieved by the South African Health Products Regulatory Authority (SAHPRA) in 2020 to the timelines historically [...]
This workshop was part of a series of global development workshops that brought together mature and maturing regulatory agencies. These workshops successively built on one another and evolved from [...]
An increasing number of National Regulatory Authorities (NRAs) are turning to reliance as a way to conserve resources, build expertise and capacity, increase the quality of their regulatory decisions, [...]
This Briefing presents the results from the CIRS annual analysis of New Active Substance (NAS) approvals by six major regulatory agencies: the European Medicines Agency (EMA), the US Food [...]
Although it cannot be expected that different medicines’ regulatory agencies always reach the same review outcome, it is important that decision making is documented and communicated to ensure transparency. [...]
This R&D Briefing summarises the outputs of breakout group discussions held during a CIRS multi-stakeholder workshop in December 2020 entitled ‘Reimagining medicine regulatory models: implementing fit-for-purpose sustainable activities for [...]
This Briefing provides an overview of how advisory committees can be used to support the regulatory decision-making process and considering the context of Latin American regulatory systems, aims to [...]
Background: Despite the growing application of facilitated regulatory pathways (FRPs), little attention has focused on assessing the perception of pharmaceutical companies regarding their usefulness beyond increasing timeliness. Objectives: The [...]
