Streamlining Postapproval Submissions Using ICH Q12 & SCDM
ISPE
AUGUST 29, 2022
Mon, 08/29/2022 - 15:46. The current lack of global harmonization for CMC content across regions requires the burdensome task of creating multiple submissions to fulfill varying regulatory requirements across different markets. The European Medicines Agency (EMA) issued its implementation guidance in March 2020. Trudy Patterson.
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