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MFDS extends the scope of subject to CTD when applying for approval

Published: 2018-06-22 11:30:20
Updated: 2018-06-22 11:30:20

It will be obligated to fill out the Common Technical Document(CTD) even for drugs with special dosage forms, such as immediate release and transdermal drugs, when applying for product approval.

Drug Standard Manager Young-Lim Kim at the Ministry of Food and Drug Safety(MFDS) National Institute of Food and Drug Safety Evaluation announced the MFDS’s future plan to make the drug quality evaluat...

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