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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
Objectives: The objectives of the study were to establish a benchmarking tool to collect metrics to enable increased clarity regarding the differences and similarities across health technology assessment (HTA) [...]
