Major changes to Australia's Therapeutic Goods Regime commence soon

New pathways to the market will soon be available to pharmaceutical companies following the passage of the Therapeutic Goods Amendment (2017 Measures No.1) Bill 2017 through both Houses of Parliament.

The Bill is part of the legislative response to the Expert Panel Review Medicines and Medical Devices Regulation. The bill makes a number of significant amendments to the Therapeutic Goods Act 1989, including by:

• creating a new class of therapeutic good to be known as ‘provisionally registered goods’ ;
• introducing a permitted indications regime for use with listed medicines; and
• establishing an additional pathway for listed complementary medicines seeking to use indications outside those permitted indications; and
• removing any distinction between advertisements for which advertising approval is, or is not, required.

The regulator, the Therapeutic Goods Administration, will also have:

• a graduated penalty regime for non-compliant sponsors; and
• strengthened monitoring and compliance powers.

The changes will commence upon Royal Assent, which is expected very soon. Sponsors should be considering how this will affect their therapeutic goods, including what opportunities it brings, and reviewing their advertising now.

Should you have any questions in relation to the nature of these changes or the other their impact on sponsors of therapeutic goods please contact Clayton Utz.