What is regulatory science and why is it important?

Regulatory science is the application of scientific principles and tools to develop regulatory frameworks and standards for assessing medicines. This supports regulators to make evidence-based decisions on medicine safety, efficacy, and quality. CIRS advances regulatory science by conducting collaborative research and bringing regulatory stakeholders together to identify and implement best practices.

What tools are used to measure the performance of regulatory systems?

Performance of regulatory systems is measured using structured tools that assess efficiency, quality, and transparency. The World Health Organization Global Benchmarking Tool (GBT) evaluates regulatory systems against international standards, supporting capacity building and system maturity. CIRS complements this with its Optimising Efficiency in Regulatory Agencies (OpERA) toolkit, which can use regulatory review process metrics to benchmark performance across regulatory agencies. More information on how CIRS OpERA tools support WHO GBT indicators can be found in R&D Briefing 87.

What challenges do regulatory agencies face in implementing risk-based reviews?

Regulatory agencies face several challenges when implementing risk-based reviews (see CIRS July 2022 workshop), including: Internal alignment and mindset shifts: Adopting reliance-based approaches often requires cultural change and buy-in from reviewers accustomed to traditional methods. Access to high-quality documentation: Agencies need timely, complete, and secure access to reference agency reports, which can be limited by redaction practices or inconsistent formats. Infrastructure and capacity: Implementing scalable and transparent risk-based frameworks demands robust systems, clear guidelines, and trained personnel. Trust and collaboration: Building confidence in external assessments and fostering collaboration across agencies is essential but can be hindered by regulatory sovereignty and differing standards. CIRS supports regulatory agencies with navigating the practical implementation of risk-based reviews, such as reliance and worksharing, through its Optimising Efficiencies in Regulatory Agencies (OpERA) programme, workshops and research projects.

Regulatory Science Tools

CIRS tools to strengthen regulatory practices and processes

CIRS has developed and validated several tools in collaboration with medicine regulatory agencies worldwide to enhance their internal practices and processes. These include metrics tools that provide evidence-based insights into agency performance, and tools to support decision making (see below).

These tools are frequently used in the Optimising Efficiencies in Regulatory Agencies (OpERA) Programme to support regulatory agencies in regulatory strengthening, performance measurement, implementation of good review practices, structured benefit-risk assessment, and quality decision-making.

Performance

Country Report

Metrics Tool

Process Efficiency and Effectiveness Rating (PEER) Questionnaire

Decision Making

UMBRA Benefit-Risk Framework

Quality Scorecard

Quality of Decision Making Orientation Scheme (QoDoS) Tool

Good Review Practices Embeddedness Survey

Frequently asked questions (FAQs)

What are regulatory science tools?

CIRS regulatory science tools are evidence-based methodologies and frameworks developed in collaboration with medicine regulatory agencies worldwide. They support regulatory strengthening, performance measurement, implementation of good review practices, structured benefit-risk assessment, and quality decision-making within regulatory systems.

How can medicine regulatory agencies strengthen regulatory systems and review processes?

Regulatory agencies can strengthen their review processes through performance measurement, implementation of good review practices (GRevP), structured decision-making approaches, and benchmarking against regulatory best practice. CIRS regulatory science tools provide practical methodologies to support these activities and identify opportunities for continuous improvement.

How do CIRS regulatory science tools support WHO Global Benchmarking Tool (GBT) implementation?

CIRS regulatory science tools support regulatory agencies in implementing and assessing a range of WHO Global Benchmarking Tool (GBT) indicators. The tools can be used to evaluate regulatory system components and processes, measure performance, strengthen good review practices, support quality decision-making, enhance transparency, and facilitate reliance and work-sharing initiatives. Together, they provide practical approaches to regulatory system strengthening and continuous improvement.