October 2011 Slide of the Month

• The slide shows a the submission lag time to Emerging Market countries after first world-wide approval, when comparing two-year cohorts ( 2006-2007 vs 2008-2009).
• These data shows that the time to submission in Russia, India and to some extent China, was faster in 2008-2009 compared with 2006-2007.  Submission timing to Brazil, Mexico, Turkey, Indonesia, South Africa. Taiwan and Argentina, however, was slower in 2008-2009 compared with 2006-2007.
• Those countries that are depicted as close to the line of identity show little or no change to the median submission time in those time periods.

Source: CIRS Emerging Markets Regulatory Review times (EMaRRet) database

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.