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Part B: Amendments to the Poisons Standard not referred to an expert advisory committee
5. Delegate-only decisions on medicines for human therapeutic use: New Chemical Entities (NCEs)
5.2 Tilmanocept
Delegate's final decision
The delegate's final decision under regulation 42ZCZU of the Therapeutic Goods Regulations 1990 (the Regulations) is to amend the Poisons Standard by creating a new Schedule 4 entry for tilmanocept as follows:
Schedule 4 - New Entry
TILMANOCEPT.
Implementation date: 1 October 2018
Reasons:
The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered by the delegate for the decision include:
- the risks and benefits of the use of a substance:
- Tilmanocept is a new chemical 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:
- Tilmanocept is a diagnostic, receptor-targeted, radiopharmaceutical developed for the detection of sentinel lymph nodes. It is indicated for imaging and intraoperative detection of sentinel lymph nodes draining a primary tumour in adult patients with breast cancer, melanoma, or localised squamous cell carcinoma of the oral cavity.
- the toxicity of a substance:
- The potential toxicity of tilmanocept includes hypersensitivity reactions, including anaphylaxis.
- Tilmanocept is Pregnancy Category C. There are no data from the use of Tilmanocept in pregnant women.
- the dosage, formulation, labelling, packaging and presentation of a substance:
- Tilmanocept will require specialised facilities and trained staff for preparation and administration and should only be administered by trained healthcare professionals with appropriate technical expertise.
Scheduling proposal
The delegate of the Secretary proposed to amend the Poisons Standard with respect to tilmanocept, a new chemical entity (NCE) for a human therapeutic medicine.
Background information for safinamide
Scheduling status
Tilmanocept is not specifically scheduled and is not captured by any entry in the Poisons Standard.
Delegate's consideration
The delegate considered the following in regards to this scheduling:
- Advice on the place in therapy of this NCE;
- The Australian Health Ministers' Advisory Council's Scheduling Policy Framework (SPF 2018); and
- Section 52E(1) of the Therapeutic Goods Act 1989 in particular: (a) the risks and benefits of the use of a substance; (b) the purposes for which a substance is to be used and the extent of use of a substance; (c) the toxicity of a substance; and (d) the dosage, formulation, labelling, packaging and presentation of a substance.