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Bulk material DMF system to be simplified in 2011
The Korea Food and Drug Administration says it is contemplating an administrative measure designed to ameliorate drug master file (DMF)-related regulations from next year, including:
- As for an applicant who intend to notify bulk materials which has been notified in the DMF list, no DMF related data will submitted to the drug agency if a corresponding DMF owner accepts the sharing of necessar...
- As for an applicant who intend to notify bulk materials which has been notified in the DMF list, no DMF related data will submitted to the drug agency if a corresponding DMF owner accepts the sharing of necessar...
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