Available to designate orphan drugs only with approval of clinical trial plan

Published: 2018-04-20 16:27:00
Updated: 2018-04-20 15:50:20

On the 18th, the Ministry of Food and Drug Safety(MFDS) pre-announced a revision bill to the ‘Regulations for Orphan Drug Designation’ which contains articles of improving regulations which allows health care authorities to designate a drug as orphan drug only with approval of clinical trial plan...

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