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Delegate-only final decisions and reasons: NCEs, September 2019

Scheduling of chemicals and poisons

25 September 2019

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1.4 Darolutamide

Final decisions on matters not referred to an expert advisory committee

1. New Chemical Entities - medicines for human therapeutic use

1.4 Darolutamide
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

DAROLUTAMIDE.

Index - New Entry

DAROLUTAMIDE

Schedule 4

Implementation date

1 October 2019

Reasons

The matters under subsection 52E(1) of the Therapeutic Goods Act 1989 considered relevant by the delegate for the decision include:

  1. 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.
  2. 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.
  3. the toxicity of a substance:
    • The toxicity of darolutamide requires ongoing clinical review by a medical practitioner.
  4. 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.
  5. the potential for abuse of a substance:
    • Nil.
  6. any other matters that the Secretary considers necessary to protect public health:
    • Nil.
Scheduling proposal

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.

Scheduling status

Darolutamide is not specifically scheduled and is not captured by any entry in the Poisons Standard.

Delegate's considerations
  • 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.

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