DMF Requirements Clarified by KFDA

Published: 2005-01-17 06:59:00

Updated: 2005-01-17 06:59:00

The Korea Food and Drug Administration (KFDA) recently provided a set of specific details surrounding the Drug Master File (DMF) requirements, under its effort to implement the Pharmaceutical Bulk Report System scheduled by September of this year.

Based on the communicated DMF guidance on proper supplementation of the existing applications, the KFDA is currently undertaking the secondary eva...

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