As the regulatory landscape changes to meet new challenges, such as increasingly sophisticated medical innovations, fundamental questions are being raised: What is the role of a ‘modern’ regulator today? [...]
Background: Benchmarking regulatory systems of low- and middle-income countries with mature systems provides an opportunity to identify gaps, enhance review quality, and reduce registration timelines, thereby improving patients’ access [...]
There is a growing trend for pharmaceutical companies to seek scientific advice on drug development from a Health Technology Assessment (HTA) perspective, to improve the efficiency of their studies, [...]
For a new medicine to reach patients, it must achieve both regulatory marketing authorisation and reimbursement from the payer. Because regulators assess the benefits and risks of a medicine [...]
Introduction: Regulatory reliance, harmonization and work sharing have grown over the last few years, resulting in greater sharing of work and information among regulators, enabling efficient use of limited [...]
Introduction: National medicines regulatory agencies are faced with challenges including limited resources and technical capacity, resulting in countries collaborating and sharing resources to improve efficiency of the review process to [...]
As part of the Optimising Efficiencies in Regulatory Agencies (OpERA) programme, CIRS has been working closely with six regulatory agencies in the Southern African Development Community (SADC) to evaluate their [...]
Background: This study was built on the previous 2018/2019 assessment where ICH selected the Centre for Innovation in Regulatory Science (CIRS) to collaborate on the development and the conduct [...]
This Briefing presents data from HTADock, an ongoing metrics study that collects data on new active substances (NASs) appraised by eight HTA agencies and analyses synchronisation between the regulatory [...]
We’re thrilled to welcome Anna Somuyiwa as the new Head of CIRS! Anna will lead the CIRS team in its mission to maintain a leadership role in identifying and [...]