1. Lowest number of NAS approvals in 2010 by both EMA and FDA in ten years
EMA: The European Medicines Agency
FDA: US Food and Drug Administration
The graph shows both the numbers (left axis) and median approval times (right axis) for NAS approved by EMA and FDA over the last decade ( ). This analysis shows that both EMA and FDA had their lowest number of approvals in 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 at (FDA 304 days and EMA 427 days) are lower than at the start of the decade (FDA 368 days and EMA 498 days). In 2010, the median approval time for NAS approved by FDA was 304 days and for EMA was 438 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 (NAS):
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 where a completely new dossier was submitted from a new company for the same indications as already approved for another company
Applications for a new or additional name, or a change of name, for an existing compound (i.e. a ‘cloned’ application)
Number of NAS approvals
* EMA approval time includes EU Commission time
Median approval time (days)*
EMA
FDA