Internationalisation of new active substances approved 2012-2014 - a focus on EMA and FDA
Slide of the Month
Survey responses regarding regulatory and HTA agency attitudes toward adaptive licensing. From Liberti et al, WHO CCPPR Winter Meeting, January 2015.
For each NAS (new active substance) approved between 2004 and 2013 by the European Medicines Agency (EMA), the United States Food and Drug Administration (FDA), Japan Pharmaceuticals and Medical Devices Agency (PMDA), Health Canada, Swissmedic and Australian Therapeutic Goods Administration (TGA), the date of submission and the date of approval by the agency were collected from the public domain or obtained from the agency.
The variability in HTA organisations and methodologies that are utilised in HTA appraisal and coverage decision-making processes in different countries results in a complex and challenging environment and it is therefore important for companies to incorporate a clear understanding of HTA requirements into early strategic planning to mitigate risk.