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 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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
The aim of the study was to evaluate the Gulf Cooperation Council (GCC) centralized regulatory review process. Regulatory review times—including submission and application dates for new active substances (NASs) [...]
