Seoul to simplify orphan drug designation

Lee Hye-seon  Published 2018.04.19  16:00  Updated 2018.04.19 16:00


The Ministry of Food and Drug Safety (MFDS) on Wednesday said it would amend regulations to allow orphan drug designation on approved clinical trials.

An orphan drug refers to a rarely used medication for treatment of a rare disease without an alternative, requiring an urgent market release. The amendments will support a quick development of treatments for rare and incurable diseases, the government said.

The amendments include expanding the scope of applicants for orphan drug designation and improving disclosure methods by changing the designation procedure for orphan drugs.

To date, only pharmaceutical manufacturers, consignment manufacturers/distributors, and importers were able to obtain the nod for orphan drug development. However, the government will allow more drug suppliers to file applications for an orphan drug, as long as they received approval.

The government also plans to simplify the procedure of orphan drug designation.

The government used to put on an administrative notice to designate an orphan drug. But from now on, the authorities will announce it on the ministry’s website. Such procedure will save time and accelerate the designation of orphan drugs, the government said.

Companies with an opinion about the upcoming amendments can submit their views to the ministry’s Pharmaceutical Policy Division by May 8.

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