Join the CIRS team
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 [...]
CIRS RD Briefing 79 – Use of advisory committees in Colombia
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 [...]
Bujar et al 2021 – Value of Facilitated Regulatory Pathways
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 [...]
Join the CIRS team
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 [...]
Sithole et al 2021 – Regulatory review process in Zimbabwe
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 [...]
Wang et al 2020 – Companies’ HTA strategies and practices
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 [...]
CIRS and CoRE sign Memorandum of Understanding to facilitate opportunities for collaboration
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 [...]
Keyter et al 2020 – A proposed regulatory review model to support SAHPRA
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 [...]
2019 Workshop report – Optimising the regulatory review process by evaluating performance and addressing good reliance practices
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 [...]
New project for ICH
We’re delighted to announce that we’ve been selected by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals (ICH) to undertake an assessment of regulatory agencies’ and companies’ perspectives [...]