TGA Looks to Replace ‘Burdensome’ Requirements for Distributing Unapproved Drugs

Australia’s Therapeutic Goods Administration is proposing to ease the requirements for access to unapproved drugs.

Under the proposal, the TGA would no longer have to process thousands of applications for access to unapproved drugs or have to assess clinical justifications for the distribution of these therapies. Instead, the TGA will rely on notifications of unapproved drug uses and singular committee assessments from the Human Research Ethics Committee. The TGA also intends to extend the duration of access to the therapies by up to three years, which would lessen the frequency of renewals.