Metrics Tool
Goal/purpose
Facilitate timeliness and effectiveness of the regulatory review process
Overview
The Metrics Tool enables medicine regulatory agencies to systematically collect, analyse, and interpret performance data across key stages of the regulatory process. It provides a consistent method for tracking review times, including company and agency time, giving a baseline against which the impact of change can be measured.
By highlighting trends, bottlenecks, and variability, the Metrics Tool supports regulators in strengthening operational efficiency and ensuring greater predictability for stakeholders. The Metrics Tool is widely used to support performance benchmarking, continuous improvement, and evidence‑based policy decisions.
Who the tool is for
Any regulatory agency, regardless of size or maturity.
How the tool works
Typically, the agency registration or information management departments undertake metrics collection. They either use a CIRS online data collection tool or record the data in an Excel spreadsheet for CIRS to process. CIRS then analyses the data and produces the Metrics Report, which includes analyses such as overall approval time against agency target, impact of product characteristics and agency pathways, and comparison of agency vs company time for various review phases.
An example of review process breakdown is shown below.
Practical use cases
CIRS has analysed regulatory review metrics for over 20 regulatory agencies and regional initiatives in Asia, Africa, North and South America, Australia, Europe, and the Middle East. The results have been used to monitor timelines, identify effective and ineffective strategies, and make comparisons to other agencies doing similar activities, identifying opportunities for learning. In addition, results from CIRS regulatory benchmarking studies have been shared in agency annual reports (e.g. Swissmedic 2025), newsletters (e.g. PMDA 2025), press releases (e.g. Swissmedic 2025), journal publications and conference presentations, helping to enhance transparency.
WHO Global Benchmarking Tool (GBT) indicators supported by this tool
- GBT MA04.06: The establishment of timelines for the assessment of applications and an internal tracking system are required to follow the targeted timeframes
- GBT MA06: The use of a mechanism to monitor regulatory performance and output
- GBT MA06.02: The establishment and implementation of performance indicators for registration and/or market authorisation activities is required
- GBT RS09.04: Information on marketed medical products, authorised companies, and licensed facilities is publicly available
- GBT RS10.01: Requirements established to monitor, supervise, and review the performance of the NRA and affiliated institutions using key performance indicators
Resources
- Hirako, M., McAuslane, N., Salek, S. et al.A Comparison of the Drug Review Process at Five International Regulatory Agencies. Ther Innov Regul Sci 41, 291–308 (2007)
- Mohd Sani, N., Kasbon, S.H., Yap, K.Y. et al. Assessing the Malaysian Regulatory Process for Medicinal Product Approval: An OpERA Methodology and Standardized Reporting Approach. Ther Innov Regul Sci (2025)
- Bujar M, Dalla Torre di Sanguinetto SA, Kermad A, Bolte C, McAuslane N. An Evaluation of the Swissmedic Regulatory Framework for New Active Substances. Ther Innov Regul Sci. 2024;58(1):153-165.
- Patel, P., Cerqueira, D.M., Santos, G.M.L. et al. A Baseline Analysis of Regulatory Review Timelines for ANVISA: 2013–2016. Ther Innov Regul Sci 54, 1428–1435 (2020)
- CIRS 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