We recently presented key findings from our latest R&D Briefing in a webinar on 'Approaches to Implementing Regulatory Reliance: Considerations for Agencies'. The webinar was attended by over 200 people [...]
This CIRS briefing delves into the increasingly pivotal role of regulatory reliance in the global pharmaceutical landscape. Reliance is defined by World Health Organization (WHO) as the act whereby [...]
Background: The Gulf Centralised Committee for Drug Registration (GCC-DR), as part of the Gulf Health Council (GHC), enables the consolidated registration of pharmaceutical products throughout the member states of [...]
The aim of this study was to explore patients’ knowledge and perspectives in Istanbul, Turkey about the pharmaceutical regulatory review and reimbursement processes with respect to access to new [...]
Background: This study was to evaluate the Turkish regulatory review process and timelines between 2016 and 2018 with a view to assess the changes that had taken place since [...]
Objective: This study compares the current regulatory review process and good review practices at the Saudi Food and Drug Authority (SFDA) with those of regulatory agencies in Australia, Canada, [...]
Objective: This study compares the current regulatory review process and good review practices at the Saudi Food and Drug Authority (SFDA) with those of regulatory agencies in Australia, Canada, [...]
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) [...]
The regulatory agencies in the Middle East and African region that were included in this study share a common goal with the research-based pharmaceutical companies that they regulate. This [...]