Posted by Michael Wonder on 07 Jun 2018
Reform of the orphan drug program - End of transition arrangements
7 June 2018 - On 1 July 2017 amendments to the Therapeutic Goods Regulations 1990 (the Regulations) came into effect that reformed the Australian orphan drug program, following public consultation in 2015 and 2016.
Changes to the program were implemented to create a fairer program that aligns more closely with international criteria without impeding the availability of drugs for rare diseases.
Orphan drug designations determined prior to 1 July 2017 will cease to be in force from 1 July 2018.
