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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 alpelisib in 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 treatment with alpelisib should be considered in consultation with 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 alpelisib requires clinical diagnosis and ongoing clinical monitoring by a medical practitioner experienced in the diagnosis and treatment of the condition.
- the toxicity of a substance:
- The toxicity of alpelisib requires regular monitoring and clinical review.
- the dosage, formulation, labelling, packaging and presentation of a substance:
- Dose interruptions and/or reductions may be required to manage toxicity.
- 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 alpelisib, a new chemical entity (NCE) for a human therapeutic medicine.
Alpelisib 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.