CIRS

2019 trends in regulatory approvals of new medicines

A study by the Centre for Innovation in Regulatory Science (CIRS) has identified trends in approvals of New Active Substances (NASs) by six major regulatory authorities1 , focusing on 2019 as well as the period from 2010 to 2019. In addition to tracking the number of approvals and the time to approval, the study also […]

Health technology assessment agencies play pivotal role in patient access to medicines

Timely recommendation for drug reimbursement by health technology assessment (HTA) agencies is critical to ensuring patient access to the medicines they need, a study by the Centre for Innovation in Regulatory Science (CIRS) has confirmed. As part of an ongoing effort to monitor regulatory and HTA performance, CIRS collected data on new active substances (NASs) […]

The impact of the changing regulatory environment on the approval of new medicines, 2007-2016

Over the last decade, 2007-2016, convergence in approval times as well as changes in strategies of multinational pharmaceuticals have resulted in more new active substances (NASs) being internationalized, referring here to receiving marketing authorization in six major regulatory agencies, namely the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), the Japan Pharmaceuticals […]

The shifting regulatory landscape impacts the review of new medicines

Major improvements in the regulatory environment in the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) countries over the last decade has led to a decrease in the time to approval as well as an increase in the number of medicines that have become available.