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Halozyme Therapeutics, Inc. Message Board

  • fezziwig2008 fezziwig2008 Apr 29, 2013 9:30 AM Flag

    EMA 67 Day Approval Period for EPAR of HyQ Over Halfway Done- May 27 Deadline

    EMA Website-
    HyQvia human normal immunoglobulin
    human normal immunoglobulin
    21/03/2013 Positive

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    • They came in under the 67 days!!!! (baby)

    • Maybe. But according to the British journal of clinical pharmacology, the EC violates this deadline 71% of the time as last measured in 2012. The average is approximately 94 days. Sometimes as much as 138 days!

      As far as EC approval from time of initial application, the average is approximately 409 days. (The FDA averages 205 days)

      On the bright side, the 2012 report thought that the EC could reduce these times. For instance, it recommended the goal for the EC be 30 days from CHMP to EC approval. Otherwise, this is clearly a competitive disadvantage for the EC in comparison to the U.S. and other countries, because the final approval is rarely denied anyway (if CHMP approved), and it is not nearly as substantively deliberate regarding safety and efficacy as CHMP. Moreover, the EC has been reviewing it all along, so they are at yet another advantage. Back in the 90s, the average time from CHMP to EC final approval was 30 days, with no discernable difference in ultimate patient safety and efficacy regarding approved drugs.

      In other words, who knows.

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