As the orphan drug market has recently emerged as Blue Ocean, the introduction of Orphan Drugs by global pharmaceutical companies is increasing in Korea.

In particular, as the MFDS has given a PMS of up to 11 years to Orphan Drugs through amendment of regulations, the market monopoly is expected to be prolonged.

According to the MFDS on the 12th, two of the recently approved Orphan Drugs have been granted PMS for more than 10 years.

PMS, which means re-examination of new drugs, is subject to investigation conditions after being marketed during the period, but it also has a data protection function, blocking entry of generic drugs, and thus gaining market monopoly.
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