11th Feb 2014, 8:17 PM – Representatives Therapeutic Goods Amendment (2013 Measures No. 1) Bill 2013 - Consideration in Detail - Scope of TGA's oversight

The majority voted against an amendment introduced by Melissa Parke.

Ms Parke explains that her amendment would have expanded the scope of the Therapeutic Goods Administration's oversight and protective function in relation to three categories:

• therapeutic goods;
• biologicals, i.e. a product involving human cells or human tissue; and
• medical devices.(Read Ms Parke's full explanation and the related debates here.)

Because the majority voted against the amendment, it was unsuccessful.

Background to the bill

The bill was introduced to to strengthen regulation and improve the operation of the Therapeutic Goods Act 1989.(Read more about the regulation of therapeutic goods more generally here. ) For example, the bill:

• enables the minister to specify products that are taken not to be therapeutic goods;
• enables the secretary to remove products that are not therapeutic goods from the Australian Register of Therapeutic Goods; and
• clarifies the secretary’s powers to approve product information for medicines accepted for registration in the register.(Read more about the bill in its bills digest. See here to read a summary of what the bill does and its explanatory memorandum.)