The Centre for Innovation in Regulatory Science (CIRS) has been awarded a phase two grant totalling $1.09m by the Bill & Melinda Gates Foundation.
The grant will allow for the continuation of the CIRS and Gates Foundation’s collaborative efforts on the Optimising Efficiencies in Regulatory Agencies (OpERA) programme to expedite patient access to medicines in areas of unmet need in low and middle-income countries (LMICs).
The grant will be used to accelerate and consolidate the activities around the OpERA programme – a unique metrics collection programme that aims to help LMICs to achieve targeted improvements in their regulatory performance goals.
The ultimate aim of the programme is to accelerate the registration of quality medicines in LMICs. Inefficiencies in regulatory systems processes, such as redundancies, can cause long and unpredictable review times for new medicines, which in turn delays their registrations.
According to CIRS, these inefficiencies can also negatively affects the authorisation of competitive generic and biosimilar medicinal products, which can impact the costs and availability of medicines.
CIRS is a neutral, independent UK-based subsidiary of Clarivate Analytics, which aims to maintain a leadership role in identifying and applying scientific principles for the purpose of advancing regulatory and health technology assessment (HTA) policies and processes.
For over 20 years, CIRS has collected marketing authorisation assessment data, especially in high-income countries, and has developed a standardised reporting approach to identify key characteristics that may impact regulatory performance. This allows for an accurate interpretation of the metrics being evaluated.
The OpERA programme combines qualitative and quantitative information to provide a detailed picture of the regulatory assessment activities of agencies at any stage of maturity.
It also provides each country with a report which shows global comparisons to similar agencies and encourages sharing and adoption of good review practices.
The grant will also be used by CIRS to provide opportunities for emerging national regulatory agencies to meet at regional forums – in Africa, Latin American and Asia – during the three year duration of the grant.
These forums will offer opportunities for agencies to share experiences and help regulators to identify new ways to improve their organisation efficiency, as well as learn about the important tools and processes that can improve their regulatory assessment practices.
“The efficient, predictable and speedy assessment and introduction of quality new medicines and vaccines to underserved patient populations continues to be a priority for the whole healthcare community,” said Jamie Munro, executive director of CIRS.
“The aims of phase two of this programme are to give regulatory agencies in LMICs the tools and information to measure themselves against the outcomes of their evolving product assessment processes; while transitioning the OpERA programme to a financially self-sustainable performance metric monitoring system for the ongoing use of participating agencies,” he added.