Background: The Brazilian health regulatory agency (Agência Nacional de Vigilância Sanitária, ANVISA) has embarked on transformational initiatives to fulfill its mandate to provide timely access to safe, effective, and [...]
A number of changes to society and the economy have emerged during the COVID-19 pandemic, which are likely to impact regulators, HTA agencies and the pharma industry. CIRS recently hosted [...]
This Briefing presents the results from the CIRS annual analysis of New Active Substance (NAS) approvals by six major regulatory agencies: the European Medicines Agency (EMA), the US Food [...]
Introduction: The National Pharmaceutical Regulatory Agency (NPRA) embarked on a regulatory-strengthening program and is evaluating its processes. Optimising Efficiencies in Regulatory Agencies (OpERA) is a regulatory-strengthening program that provides [...]
The Southern African Development Community (SADC) collaborative medicines registration initiative ZaZiBoNa is a successful regional work-sharing initiative on the African continent. This paper reviews the history of the ZaZiBoNa [...]
An efficient regulatory process can be reflected in measurable positive health impacts; conversely, activities that slow or impede regulatory efficiency and predictability can be detrimental. Recent developments in the [...]
Unfortunately, given current circumstances, we have had to postpone our June workshop. Please see below for our revised list of workshops. 15-16 September, Bogota, Columbia Effectiveness of the regulatory [...]
It has become clear that agencies have a number of pathways that can be used during public health emergencies for the authorisation of therapeutics and vaccines. Some of these so-called [...]
We’re delighted to announce that we’ve been selected as a Technical Resource Partner for the Promoting the Quality of Medicines Plus (PQM+) programme, which is funded by the US Agency [...]
Unfortunately, given current circumstances, we have had to postpone our March workshop. Please see below for our revised list of workshops. 11-12 June, Tyson's Corner, USA Digital health: exploring the [...]