✦ Plain-English Summary

Therapeutic Goods Amendment (2020 Measures No. 1) Bill 2020

What it does

This bill updates the rules for how medical devices and medicines are approved and regulated in Australia. It makes changes to how devices get certified, allows faster approval pathways for clinical trials and new medicines, and creates new ways for doctors to prescribe certain treatments.

Why it matters

These changes speed up access to new medical treatments while keeping safety checks in place. They also give doctors more flexibility to prescribe medicines in ways that might help patients, and they reduce red tape for companies developing new devices and drugs.

Key details

• Medical devices: Manufacturers can now have entries removed from the register if devices are no longer made, and there's clearer guidance on what counts as a medical device in the first place.

• Faster approvals: Companies can get advice from regulators early in development, and clinical trial variations can be approved more quickly without starting the whole process again.

• Doctor flexibility: The "authorised prescriber scheme" now lets qualified doctors supply certain medicines directly to patients without going through a pharmacy—useful for specialists treating specific conditions.

• Rollout timing: Most changes kick in the day after the bill receives Royal Assent, though some medical device rules had a later start date (28 days after, or 25 August 2020, whichever came later).

Official Description

Amends the: Therapeutic Goods Act 1989 to: align certain device-related definitions with the equivalent definition in the European Union; enable the secretary to provide early scientific advice to a sponsor about the safety, quality or efficacy of a registrable medicine; enable a clinical trial sponsor to request variations to approved clinical trials; introduce a new preliminary assessment procedure for applications for new ingredients for listed and assessed listed medicines; remove a limitation on the circumstances in which medical practitioners may be authorised to supply specified unapproved therapeutic goods to their patients; remove certain offences for persons claiming to be able to arrange supply of therapeutic goods; impose a condition of registration or listing of therapeutic goods; specify the circumstances in which a sponsor may apply for the provisional registration of a medicine, without having to first obtain a provisional determination; introduce a data protection regime for assessed listed medicines; and make minor amendments and corrections; and Patents Act 1990 to remove a reference to therapeutic devices.

Committee Referrals

Senate Standing Committee for the Scrutiny of Bills

No formal division recorded

This bill passed by voice vote — parliament agreed without calling a formal count. A division is only recorded when a member explicitly requests one.

No votes yet.

No votes were recorded for this bill.