Orphan drug designation rules to be largely revised for rapid development

In order to enlarge therapy options for rare or incurable disease patients, regulations about designation of orphan drugs will be modified.

The Ministry of Food and Drug Safety(MFDS) pre-announced the partial revision bill to the ‘Regulations about Designation of Orphan Drugs’ which mainly contains articles about enlarging the range of applicants for orphan drugs to rapidly introduce drugs wit...