Australian company ordered to pay $10 million for unacceptable advertising claims: TGA uses its power to penalise inappropriate online advertisement and sale of therapeutic goods

Justice Jagot found Peptide Clinics Pty Ltd (Peptide Clinics) (now in liquidation) had contravened several provisions of the Therapeutic Goods Act 1989 (Cth) (TG Act), including making claims that breached the Therapeutic Goods Advertising Code.  Justice Jagot has ordered Peptide Clinics to pay a pecuniary penalty to the Commonwealth of $10 million in respect of the contraventions. read more...

Biosimilars: balancing access to affordable medicines with safety

Biological medicines (biologics) are agents derived from a biological source.  As a consequence, they are complex and there is a high degree of variability between molecules of the same active substance.  Biosimilars are medicines that are closely related, pharmaceutically and therapeutically, to their reference biologic.  However, biosimilars are not identical to, and cannot be characterised read more...
Subjects: Uncategorized

Drugs in the fast lane: provisional drug registration and other proposed changes to the Therapeutic Goods Act

Following the Australian Government’s Response to the Review of Medicines and Medical Devices Regulation in 2016, the government recently released exposure drafts for a set of significant reforms to the Therapeutic Goods Act 1989 (Cth). The proposed changes include modifications to the regulation of complementary medicines, and a new class of “provisionally registered goods”.  This read more...
Subjects: Patents