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Delegate-only final decisions and reasons: NCEs, September 2019
Scheduling of chemicals and poisons
Final decisions on matters not referred to an expert advisory committee
1. New Chemical Entities - medicines for human therapeutic use
Delegate's final decision
The delegate's final decision under regulation 42ZCZU of the Therapeutic Goods Regulations 1990 is to include darolutamide in Schedule 4 of the Poisons Standard as follows:
Schedule 4 - New Entry
Index - New Entry
1 October 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:
- The risks and benefits of darolutamide require the involvement of a medical practitioner experienced in the diagnosis and treatment of the condition.
- the purposes for which a substance is to be used and the extent of use of a substance:
- The use of darolutamide should be managed by a medical practitioner experienced in the diagnosis and treatment of the condition.
- the toxicity of a substance:
- The toxicity of darolutamide requires ongoing clinical review by a medical practitioner.
- the dosage, formulation, labelling, packaging and presentation of a substance:
- Ongoing clinical monitoring is required to determine whether dose interruptions and/or reductions are required.
- 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 darolutamide, a new chemical entity (NCE) for a human therapeutic medicine.
Darolutamide 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 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.