Roadmap for Regulatory Performance
Every regulatory authority in the world has an ambition to improve its performance. In order to achieve this, agencies often establish performance indicators which they use for measuring and [...]
Patel et al 2020 – Analysis of regulatory review timelines for ANVISA
Background: The Brazilian health regulatory agency (Agência Nacional de Vigilância Sanitária, ANVISA) has embarked on transformational initiatives to fulfill its mandate to provide timely access to safe, effective, and [...]
Mohd Sani et al 2020 – Evaluation of the Malaysian regulatory process using OpERA methodology
Introduction: The National Pharmaceutical Regulatory Agency (NPRA) embarked on a regulatory-strengthening program and is evaluating its processes. Optimising Efficiencies in Regulatory Agencies (OpERA) is a regulatory-strengthening program that provides [...]
CIRS RD Briefing 74 – OpERA programme
CIRS has collected regulatory assessment data for over 20 years, initially with ICH and ICH-observing countries. The OpERA programme, “Optimising Efficiencies in Regulatory Agencies (OpERA)”, was initiated through CIRS [...]
Keyter et al 2019 – Evaluation of the performance of the South African regulatory agency
Background: Timely access to new medicines may be addressed through strengthening of registration efciencies and timelines by establishing and refning value-added registration processes, resources, and systems. The aims of [...]
Keyter et al 2019 – South African Medicines Control Council: Comparison of Its Registration Process
Introduction: Comparisons between regulatory authorities of similar size and regulatory characteristics facilitate value-added benchmarking and provide insight into regulatory performance. Such comparisons highlight areas for improvement as authorities move [...]
2018 Workshop report – Practical implementation of reliance models
This Workshop was a follow-on from that held in 2017 in Sao Paulo entitled “Facilitating the review of new medicines through risk-based evaluations: How can a stratification process be [...]
2017 Workshop report – Facilitating review through risk-based evaluations
This Workshop built on previous CIRS global development workshops as well the work being undertaken by various groups in the areas of good regulatory and review practices and focused [...]
2016 Workshop report – Key performance metrics for regulatory processes
WHAT ARE THE KEY PERFORMANCE METRICS THAT AGENCIES AND COMPANIES SHOULD USE TO MEASURE REGULATORY PROCESSES AND PRACTICES TO FACILITATE THE LICENSING OF NEW MEDICINES? 3-4 FEBRUARY 2016, KUALA [...]
Al-Rubaie et al 2015 – Agency and industry views of the efficiency of the Gulf centralised registration procedure
The aim of this study was to examine the views and experiences of the Gulf Cooperation Council (GCC) states and pharmaceutical companies to identify the strengths and weaknesses of [...]