Introduction: European countries are increasingly utilising health technology assessment (HTA) to inform reimbursement decision-making. However, the current European HTA environment is very diverse, and projects are already underway to [...]
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 [...]
Regulatory approval time is a key metric that is used to evaluate the performance of regulatory agencies. A new methodology has been developed to compare the regulatory review process [...]
The Institute for Regulatory Science is currently involved in several activities related to quality as it applies to regulatory submissions and procedures, rather than the more conventional association with [...]
The emerging markets of Asia-Pacific, the Middle East, Africa and Latin America are becoming increasingly important to pharmaceutical companies in their global strategies for the registration of new medicines [...]
The Regulatory Agencies in Latin America share a common goal with the research-based pharmaceutical companies that they regulate. This is to ensure that new medicines become available to patients [...]
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 [...]