The TGA sought comments from interested parties on the orphan drugs program discussion paper in a consultation that closed on 15 June 2015.

A total of 30 submissions were received. Of those submissions, 10 were from pharmaceutical companies, 7 from consumer organisations, 4 from industry organisations and 3 from Government bodies. The remaining 6 submissions were from regulatory affairs organisations, professional bodies and other miscellaneous organisations/individuals. All submissions that gave permission to be published on the TGA website are now available below in PDF format.

For more details, go to: http://www.tga.gov.au/submissions-received-orphan-drugs-program