Access delayed, access denied

Nevertheless, because of the importance of the American and European markets throughout the world, the actual minimum time spent during drug development is deter- mined by the clinical testing time necessary to satisfy the requirements of the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA). [...] For the purposes of this report, the global development time for new medicines is assumed to be a function of factors outside of Canada’s control; therefore, the time associated with this segment is presented for complete- ness but is not the focus of the main policy discussion in this paper, nor is it part of the overall wait time for access to new medicines measured here. [...] In Canada, the time patients spend waiting for the federal government’s approval of a new drug is measured from the date the drug manufacturer’s application for approval is recorded or filed in the Central Registry (CR) of Health Canada’s Therapeutic Products Directorate (TPD) or Biologics and Genetics Therapies Directorate (BGTD) following the completion of clini- cal testing. [...] Since 2004, the equivalent authority to approve pharmaceutical and biological medicines in the United States has fallen under the Department of Health and Human Services (HHS) with the Center for Drug Evaluation and Research (CDER), a part of the Food and Drugs Administration (FDA). [...] Figure 3 displays the average number of days spent waiting for the approval of new medicines in the European Union and Canada in 2006 and 2007, the only years for which comparable data are available (due to changes in data reporting by the European Medicines Agency).