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

Scheduling of chemicals and poisons

28 November 2019

Scheduling amendments not referred to expert advisory committee

Subdivision 3D.3 of the Therapeutic Goods Regulations 1990 (the Regulations) sets out the procedure to be followed where the Secretary receives an application under section 52EAA of the Therapeutic Goods Act 1989 (the Act) to amend the current Poisons Standard and decides not to refer the proposed amendment to an expert advisory committee. These include, under regulation 42ZCZU, that the Secretary decides to make a final decision in relation to the proposed amendment without an interim decision. If the final decision is to amend the current Poisons Standard, the Secretary must, in doing so, take into account the matters mentioned in subsection 52E(1) of the Act (including, for example, the risks and benefits of the use of a substance, and the potential for abuse of a substance) and the scheduling guidelines as set out in the Scheduling Policy Framework for Medicines and Chemicals.

In accordance with 42ZCZX of the Regulations, the Secretary publishes here the scheduling final decision, the reasons for that decision and the date of effect (for decisions to amend the current Poisons Standard, this will be the date when it is expected that the current Poisons Standard will be amended to give effect to the decision). These Secretary's final decisions and reasons related to new therapeutic Prescription Only medicines known as New Chemical Entities (NCEs).

Final decisions on matters not referred to an expert advisory committee

1. New Chemical Entities - medicines for human therapeutic use

1.1. Talazoparib

Delegate's final decision
Final decision

The delegate's final decision under regulation 42ZCZU of the Therapeutic Goods Regulations 1990 is to include talazoparib in Schedule 4 of the Poisons Standard as follows:

Schedule 4 - New Entry

TALAZOPARIB.

Index - New Entry

TALAZOPARIB

Schedule 4

Implementation date

1 December 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:
    • As below.
  2. the purposes for which a substance is to be used and the extent of use of a substance:
    • The ailment that the substance is used for requires medical intervention (diagnosis, management and monitoring) before and while the substance is used.
  3. the toxicity of a substance:
    • The seriousness, severity and frequency of adverse effects are such that monitoring or intervention by a medical practitioner is required to minimise the risk of using the substance.
    • The seriousness or severity and frequency of the interactions of the substance (medicine-medicine, medicine-food, or medicine-disease) are such that monitoring or intervention is required by a medical practitioner.
  4. the dosage, formulation, labelling, packaging and presentation of a substance:
    • Nil.
  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 talazoparib, a new chemical entity (NCE) for a human therapeutic medicine.

Scheduling status

Talazoparib 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; and (c) the toxicity of a substance.