New active substance median approval time for six regulatory authorities in 2006-2015
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.
Prior to the inception of the Common Drug Review (CDR) in 2002, multiple provincial, territorial and federal drug plans performed their own HTA to determine coverage for new drugs. The Canadian Agency for Drugs and Technologies in Health (CADTH) established the CDR to standardise the Canadian HTA environment by reducing the duplication of HTA and ultimately decrease the time taken for patients to access new and innovative medicines.
For each NAS (new active substance)approved between 2009 and 2013 by the three International Conference on Harmonisation (ICH) agencies, European Medicines Agency (EMA), United States Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), the therapeutic area as well as the date of submission and the date of approval by the agency were collected from the public domain.
Objective To find the association between duration of the process of marketing authorization (MA)approval at European Medicines Agency (EMA) and health technology assessment (HTA) recommendations in European Union (EU) countries Methods EMA MA timing for new active substances (NASs) during 2007-2009 were analyzed based on publicly available information.…
Understanding the benefit-risk (BR) profile of a medicine is a key aspect of ensuring that the appropriate medicine is being prescribed to the right patient. The FDA and European Medicines Agency have made BR assessment and communication to patients a priority in their