Pursuant to Articles 3 and 23 of the “Rare Diseases and Orphan Drugs Act” and Articles 151 and 154 of the Administrative Procedure Act, the MOHW drafted an advance announcement about the revision of the drug items eligible for the Rare Diseases and Orphan Drugs Act.
The draft announcement includes Onasemnogene abeparvovec (solution for intravenous infusion, 2X1013vg/mL) for treating patients under 6-month old with spinal muscular atrophy due to a genetic defect in the SMN1 gene into the scope of the aforementioned Act.
Details of the advance announcement are available to download from the Executive Yuan Gazette Online, the MOHW’s website, the TFDA’s website and the National Development Council’s webpage.
Any suggestions about this advance announcement should be made within 14 days from the next day of the publication of this announcement on the gazette. Comments should be submitted via the aforementioned “MOHW Regulation Search System” or the “Public Policy Participation Platform”, or be sent to the TFDA directly.
【2020-02-10 / TFDA News】
