Country Report
Goal/purpose
Enable transparent processes and practices aligned with best practice
Overview
The Country Report provides a structured assessment of a national medicine regulatory system. It reviews a regulatory agency’s organisational set‑up, types of review models used to assess medicines, key milestones in the review process, and the extent to which Good Review Practices and the quality of decision-making practices are in place. Together, these elements offer a comprehensive overview of strengths, challenges, and opportunities for improvement.
The Country Report helps agencies understand their current state and identify areas for capacity building and strategic development. It is often used as a foundation for long‑term improvement planning and as a benchmark against international practices.
Who the tool is for
Any regulatory agency, regardless of size or maturity.
How the tool works
The Country Report is based on the Country Questionnaire completed by the regulatory agency, with a particular focus on registration departments. The Country Questionnaire is available in English, Spanish, and French. The Country Report is developed using a standardised approach to identify the key components of the review and the practices, including characteristics that may impact regulatory performance and practices.
Practical use cases
CIRS has prepared over 30 Country Reports for national regulatory authorities and regional bodies in Asia, Africa, North and South America, Australia, Europe, and the Middle East. These stakeholders have used these reports to conduct an internal gap analysis to identify alignment with best practice and opportunities for improvement. In addition, they have used the reports to monitor changes to processes over time, make comparisons with other agencies, and enhance transparency through external publications and presentations.
Examples of published studies using OpERA Country Reports can be found under ‘Resources’ below.
WHO Global Benchmarking Tool (GBT) indicators supported by this tool
- GBT RS03.05: The NRA is required to promote good regulatory practices (GRPs)
- GBT RS01.02: Legal provision and regulations define the institutions that are involved as part of the regulatory system, as well as their mandates, functions, roles, responsibilities, and enforcement powers
- GBT RS03.04: Reliance on the decisions of other mature NRAs through documented policy, procedures, and/or mechanisms must be formalised
- GBT RS07.02: The amounts collected for fees, taxes, tariffs, or dues payable for the services provided are defined and publicly available.
Resources
- Owusu-Asante M, Darko DM, Semete-Makokotieia B, et al. Regulatory Performance of African National Medicines Regulatory Authorities Achieving WHO Maturity Level 3: Identifying Best Practices. Ther Innov Regul Sci. Published online October 27, 2025.
- 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