Proposed amendments to the Therapeutic Goods Regime

31 Aug 2017

The TGA has today announced that it is seeking comments from interested parties on the exposure draft Bills amending the Therapeutic Goods Act 1989 and the Therapeutic Goods (Charges) Act 1989.

The Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017 is part of the legislative response to the Expert Panel Review Medicines and Medical Devices Regulation. The TGA has stated that the Bill is intended to:

  • "establish a scheme for the provisional approval of promising new medicines
  • streamline and simplify the framework for advertising therapeutic goods to the public
  • enhance the regulation of complementary medicines; and
  • strengthen monitoring and compliance provisions."

The Therapeutic Goods (Charges) Amendment Bill 2017 is intended to "enable annual charges to be levied for Australian conformity assessment bodies and for provisionally registered goods."

The TGA has invited "concise submissions on "show stopper" issues with the clarity, readability and complexity of the draft Bills".

Submissions are requested by 9am on 5 September 2017.

It is anticipated that the Bills will be introduced to Parliament on 13 September 2017.

Consultation: Therapeutic Goods Advertising Code

The TGA has today also announced that it is seeking comments from interested parties on proposed changes to the Therapeutic Goods Advertising Code.

The stated purpose of this consultation is "to provide an opportunity for interested parties to provide their views on proposed changes to the Code to support the implementation of related Review recommendations and a possible framework for advertising of Schedule 3 medicines to the public."

Submissions are requested by COB on 13 October 2017.

Clayton Utz communications are intended to provide commentary and general information. They should not be relied upon as legal advice. Formal legal advice should be sought in particular transactions or on matters of interest arising from this communication. Persons listed may not be admitted in all States and Territories.