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

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 to support rapid development of rare and incurable diseases.

According to the revision plan, altho...