1. New active substances approved by EMA and FDA over 10 years
The graph shows both the numbers (left axis) and median approval times (right axis) for new active substances (NASs) approved by the EMA and FDA over the last decade (2002–2011). This analysis shows that in 2011, the number of NASs approved by both the EMA and FDA outpaced Analysis of median approval times (date of submission to date of market authorisation) indicates that although there is year-on-year variation in median approval times, the median approval times from 2007–2011 (FDA ,304 days and EMA, 434 days) were shorter than from 2002–2006 (FDA, 305 days and EMA ,499 days). In 2011, the median approval time for NASs approved by the FDA was 304 days and for the EMA was 447 days.
Source: CIRS Regulatory Approval Times Database (RRTD), which tracks NAS approvals for EMA, FDA, PMDA, Australian TGA, Health Canada and Swissmedic.
New active substances (NASs):
This includes chemical, biological and radiopharmaceutical substances that have not been previously available for therapeutic use in humans to be used for the cure, alleviation, treatment, prevention or in vivo diagnosis of diseases in humans.
This term also includes: An isomer, mixture of isomers, a complex or derivative or salt of a chemical substance previously available as a medicinal product but differing in properties with regard to safety and efficacy from that substance previously available; a biological substance previously available as a medicinal product, but differing in molecular structure, nature of source material or manufacturing process; a radiopharmaceutical substance that is a radionuclide or a ligand not previously available as a medicinal product. Alternatively, the coupling mechanism linking the molecule and the radionuclide has not been previously available.
Applications that are excluded from the study: vaccine; any active substance that has previously been approved either by the EMA or by a member state; any other application, where new clinical data were submitted; generic applications; those applications in which a completely new dossier was submitted from a new company for the same indications as already approved for another company; and applications for a new or additional name, or a change of name, for an existing compound (i.e. a ‘cloned’ application).
* EMA approval time includes EU commission time