Over the last 20 years, CIRS has been developing regulatory science tools to increase transparency of processes, support quality regulatory decision making, and provide global advocacy in support of regulatory and HTA strengthening. CIRS’ tools have been developed with companies, NRAs, and academics, validated and implemented by organisations, and applied practically in projects. In a recent study, CIRS tools have supported the goals of specific GBT sub-indicators in assessing and improving the performance and the scientific competencies of NRAs (Keyter et al., 2020)
These tools form part of a comprehensive toolkit to support the CIRS “Optimizing Efficiencies in Regulatory Agencies (OpERA)” programme, a multi- year programme supported in part by the Bill and Melinda Gates Foundation, for NRAs to support regulatory monitoring and strengthening.
The objectives of OpERA are to:
• Understand the regulatory processes that drive assessment and approval times
• Encourage systematic re-assessment of the medicines’ review processes
• Provide a basis for comparison across processes used in the review of marketing authorisations
• Provide a simple process to collect benchmarking data specific to the regulatory review and assessment processes
• Encourage the development of a systematic approach to self-monitoring and continuous improvement
• Support regulators as they integrate best practices that are fit for purpose and within the agency remit, while ensuring the safety, efficacy, and quality of their products, in line with the WHO GBT
Over 30 national regulatory authorities and several regional initiatives have participated in the OpERA Programme since its inception in 2013, and many have subsequently utilised and implemented CIRS tools. The programme has successfully built a culture of measurement and refinement within participating NRAs, helping them to define their performance goals for medicines’ review and optimise review processes.
This briefing describes in detail the tools that integrate the CIRS OpERA toolkit, the utility of each tool when complying with specific WHO-GBT indicators, practical examples in which such tools have been used as well as their associated benefit.
Please cite this article as: Centre for Innovation in Regulatory Science (2023) R&D Briefing 87: Roadmap for Regulatory Strengthening: CIRS Tools for Measuring and Optimising Regulatory Performance to support practices in line with the World Health Organization (WHO) Global Benchmarking Tool (GBT) indicators. Centre for Innovation in Regulatory Science (CIRS), London, UK
