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Scheduling delegate's final decisions, June 2016
Scheduling of medicines and poisons
5.4 Follitropin delta
Part B - Final decisions on matters not referred to an expert advisory committee
5. New Chemical Entities - medicines for human therapeutic use
5.4 Follitropin delta
Delegate's Scheduling proposal
The delegate considered an application from the Therapeutic Goods Administration (TGA) for the scheduling of follitropin delta, a new chemical entity for a human therapeutic medicine.
Follitropin delta is a novel human recombinant follicle-stimulating hormone (rhFSH) intended for controlled ovarian stimulation (COS) in women undergoing assisted reproductive technology (ART) therapy such as in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI).
Follitropin delta is indicated for controlled ovarian stimulation for the development of multiple follicles in women undergoing assisted reproductive technologies (ART) such as an in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycle.
Follitropin delta is not specifically scheduled and is not captured by any entry in the current Standard for the Uniform Scheduling of Medicines and Poisons.
Delegate’s interim decision
The delegate decided to make a delegate-only decision to include this to Schedule 4. The Advisory Committee on Medicines Scheduling was not consulted.
The delegate considered the following in regards to this application for scheduling:
- Subsection 52E(1) of the Therapeutic Goods Act 1989;
- The Scheduling Policy Framework scheduling factors;
- The new drug application.
The delegate noted that currently there are no issues of concern that require additional control other than by inclusion in Schedule 4.
Delegate's final decision
The delegate has made a final decision to amend the Poisons Standard to include follitropin delta in Schedule 4, with an implementation date of 1 October 2016.
The delegate decided that the relevant matters under subsection 52E(1) of the Therapeutic Goods Act 1989 is (a) the risks and benefits of the use of a substance.
The delegate decided that the reasons for the final decision comprise the following:
- It is a new chemical entity with no clinical/marketing experience in Australia.
The delegate has decided that the wording for the schedule entry will be as follows:
Schedule 4 - New Entry