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 [...]
CIRS currently has three vacancies open: Head of CIRS This position will lead the CIRS team in its mission to maintain a leadership role in identifying and applying scientific [...]
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 [...]
CIRS currently has two vacancies open: Head of CIRS This position will lead the CIRS team in its mission to maintain a leadership role in identifying and applying scientific [...]
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: Health technology assessment (HTA) has increased in importance in supporting payer decision making by assessing the relative effectiveness and cost effectiveness of new medicines. Thus, pharmaceutical companies need to [...]
We are proud to announce that a Memorandum of Understanding (MoU) is now in place between the Centre for Innovation in Regulatory Science (CIRS) and the Duke-National University of [...]
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 [...]
