A universal framework for the evaluation of the benefit-risk assessment of medicines during development by pharmaceutical companies and in the regulatory review by regulatory authorities is considered of value, [...]
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) [...]
As part of the ongoing study to monitor regulatory performance, CIRS has analysed the trends in new medicines’ approval between 2004 and 2013 by six regulatory authorities including Health [...]
In 2013, the overall number of New Active Substances (NASs) approved by EMA, FDA and PMDA was comparable across the three agencies. Nevertheless, despite this similarity, the number of [...]
Objective: To review NASs first launched between 2005‐2010 and to determine their regulatory status as of 31 December 2012 in USA, Europe, Japan, Canada, Switzerland and Australia to identify [...]
As a first step in the implementation of the Asia-Pacific Economic Cooperation (APEC) Best Regulatory Practice Project, the Centre for Innovation in Regulatory Science conducted a gap analysis survey [...]
Active Substances (NASs) approved by both the FDA and PMDA represented the largest number of new medicines approved this decade. Regulatory approvals by EMA were lower than the other [...]
Lag Time (the time from which a product has been granted market authorisation in its first market to the time that its application is submitted for review by an [...]
In 2011, the number of New Active Substances (NASs) approved in all the ICH countries increased compared to 2010, and FDA represented the largest number of new medicines approved [...]
An efficient review depends not only on timely approval but also on ensuring the quality of the process from construction of the dossier to the ultimate regulatory decision. Two [...]