Background This study sought to identify criteria and current practices for implementing an abridged review process and understanding barriers and enablers in utilizing reliance models and to offer recommendations [...]
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 [...]
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 [...]
Objective To compare review outcome alignment between European Medicines Agency (EMA) and US Food and Drug Administration (FDA) for medicines approved by both agencies in the time period 2014–2016. Design [...]
Timely recommendation for drug reimbursement by health technology assessment (HTA) agencies is critical to ensure that patient access to medicines of therapeutic value is not delayed. As part of an [...]
To address the complex challenges in the global regulatory environment and the growing demand for patient access to new medicines, regulatory agencies in Latin America are actively engaging in regulatorystrengthening [...]
To address the complex challenges in the global regulatory environment and the growing demand for patient access to new medicines, regulatory agencies in Asia are actively engaging in regulatory-strengthening and [...]
Major improvements in the regulatory environment as well as changes in strategies of multinational companies have led to a general decrease in the time to marketing authorisation and improved consistency [...]
