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 [...]
Purpose: The aims of this study were to assess the current regulatory review process of the Medicines Control Authority of Zimbabwe (MCAZ), identify key milestones and target timelines, evaluate [...]
Background: National regulatory agencies of various sizes and maturity levels, including the South African Health Products Regulatory Authority (SAHPRA), have had to revise systems and re-engineer processes in order [...]
This workshop was part of a series of workshops on reliance, which continues to be an important area of focus for CIRS. It builds on the outcomes of a [...]
This workshop was a follow-on from a collaborative forum held in Utrecht in 2018 entitled What new research can enable a joint approach by regulatory and HTA agencies to [...]
Background: The Caribbean Regulatory System is a centralized medicine assessment procedure established to serve the needs of the Member States of the CARICOM region. In order to better understand [...]
