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    EMA takes longer time but has higher approval rate.
    (I read from the other article, data suggest average days for EMA: 409 days, FDA: 205 days)

    Europe has often been seen as a lagging regulatory agency, it appears that much of the delay to market is due to companies filing later in Europe than the US, and the time between CHMP opinion (Approval decision) and EMA ratification." Akie continued, "Drugs approved in recent years had fairly similar regulatory timelines in both the US, and EU, with the EU approving drugs at a higher rate."


    - See more at: http://globenewswire.com/news-relea...-EMA-Approval-Rates.html#sthash.FGyGo5V9.dpuf
    Last edited by 8horse: 26/02/15
 
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