Bill
Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017
passed, as at 2018-03-05. Health portfolio.
- Sponsor
- Not recorded
- Portfolio
- Health
Recorded stages
- introduced — 2017-09-14
- second reading — 2017-09-14
- second reading — 2017-10-25
- other — 2017-10-25
- second reading — 2017-12-04
- second reading — 2017-12-04
- other — 2017-12-04
- third reading — 2017-12-04
- introduced — 2017-12-04
- second reading — 2017-12-04
- second reading — 2018-02-05
- second reading — 2018-02-15
- second reading — 2018-02-15
- committee — 2018-02-15
- third reading — 2018-02-15
- other — 2018-02-15
- passed — 2018-02-15
- royal assent — 2018-03-05
Divisions
No divisions recorded. Most questions are decided on the voices; this does not establish that a bill was unopposed.
Plain-language summary
Written by a model from the explanatory memorandum; not the record, as at 2017-09-14.
This bill would implement further recommendations from a review of medicines and medical devices regulation, including creating a faster approval pathway for certain new medicines.
It would allow provisional marketing approval for promising prescription medicines based on early clinical data, with a two-year registration period that can be extended twice.
The bill would also require sponsors of listed complementary medicines to only use pre-approved indications, and would establish a new assessment pathway for intermediate-risk complementary medicines.
- Creates a new class of provisionally registered goods on the Australian Register of Therapeutic Goods.
- Requires sponsors of listed complementary medicines to certify that each indication is on a permitted list set by the Minister.
- Establishes an additional assessment pathway for intermediate-risk complementary medicines that seek indications outside the permitted list.
- Strengthens post-market monitoring powers for biologicals, including adding record-keeping to standard conditions.
- Allows sponsors of listed complementary medicines that have undergone efficacy assessment to indicate this on promotional materials and labels.
- Broadens investigation and enforcement powers under the Therapeutic Goods Act 1989.
Sponsors of prescription medicines and complementary medicines, the Department of Health through the Therapeutic Goods Administration, and the Secretary of the Department of Health.
Sources
em
em supp
em supp
billhome
frl act