1. Median times to submission and licensing for 70 new active substances approved in five markets from 1997 to 2010
Note: EMA approval time includes EU commission time
The slide shows two analyses of 70 new active substances (NASs) that were approved in the US, EU, Canada, Switzerland and Japan between 1997 and 2010:1) The median time from submission to the first of the five agencies and the time taken to be submitted to the other agencies and 2) the median approval time for the 70 NASs in each of the countries. The analysis shows that for these agencies, first submission has been to the FDA and EMA, with the time taken to submit to Canada and Switzerland being similar at around 150 to 180 days after first submission and followed by submission to Japan approximately 2.5 years later. The median approval times for the 70 NASs were 214 days in the US, 363 days in Switzerland, 406 days in Canada, 435 days in the EU and 532 days in Japan.
Source: CIRS Regulatory Review Times Database.
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).