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 [...]
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 [...]
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 [...]
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 [...]
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) [...]