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The baseline study of Malaysia's approval times: 25 new active substances and one biosimilar approved in 2017 took a median of 515 days, of which NPRA took 166 and applicants 131 to answer questions.
Using the OpERA tool, the authors collected milestone data for the 25 new active substances and 1 biosimilar approved by NPRA in 2017 to see where time was spent and to set a baseline for improvement.
It explains why the 245-working-day target and the measured time differ: much of the elapsed time was queuing before review and rounds of questions to the applicant.
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