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 [...]
Dr Liberti presents on Facilitated Regulatory Pathways
Last week CIRS Head of Regulatory Collaborations and RAPS board member Dr Lawrence Liberti discussed "Challenges and Opportunities for Using Facilitated Regulatory Pathways (FRPs) in Mature and Emerging Markets" as [...]
2019 Workshop report – Identifying and understanding uncertainty during development
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 [...]
Liberti et al 2020 – Evaluation of the Caribbean Regulatory System centralised assessment process
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 [...]