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Part B - Final decisions on matters not referred to an expert advisory committee
4. New Chemical Entities - medicines for human therapeutic use
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Delegate's final decision
The delegate's final decision is to amend the Poisons Standard to include semaglutide in Schedule 4 as follows:
Schedule 4 - New Entry
Index - New Entry
1 June 2019
The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the delegate for the decision include:
- the risks and benefits of the use of a substance:
It is a new biological entity with no clinical or marketing experience in Australia.
- the purposes for which a substance is to be used and the extent of use of a substance:
Semaglutide is a long-acting glucagon like peptide-1 (GLP-1) receptor agonist (GLP=1RA), with suggested indication for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:
- as monotherapy when metformin is considered inappropriate due to intolerance or contraindications
- in addition to other medicinal products for the treatment of type 2 diabetes
- the toxicity of a substance:
No known major/serious toxicities
- the dosage, formulation, labelling, packaging and presentation of a substance:
No specific requirements over existing regulations and guidelines
- the potential for abuse of a substance:
- any other matters that the Secretary considers necessary to protect public health:
The delegate of the Secretary proposed to amend the Poisons Standard with respect to semaglutide, a new chemical entity (NCE) for a human therapeutic medicine.
Semaglutide is not specifically scheduled and is not captured by any entry in the Poisons Standard.
- Advice on the place in therapy of this NCE;
- Scheduling Policy Framework (SPF 2018); and
- Section 52E(1) of the Therapeutic Goods Act 1989.