Posted by Michael Wonder on 26 Jun 2017
Orphan drug program reforms
26 June 2017 - The objective of the orphan drug program is to provide an incentive to sponsors to bring medicines for a small population to market and make medicines available to patients who would not otherwise be able to access them.
In 2015 and late 2016, we consulted publicly on proposed changes to the orphan drug program. At this time, the orphan drug eligibility criteria had not been reviewed in almost 20 years and changes to the Program were proposed to ensure that it is still fulfilling its intended purpose.
These consultations have resulted in reforms that will create a fairer program that aligns more closely with international criteria without impeding the availability of drugs for rare diseases. Please see the submissions received and TGA response for further information.
