Pharmacy Daily | New scheduling processes

THE Secretary of the Department of Health and Ageing will become the ultimate decision-maker on scheduling of medicines and chemicals in Australia, under changes to processes confirmed today by the Therapeutic Goods Administration. The changes have already been foreshadowed, and will become effective 01 July this year. The current decision-maker, the National Drugs and Poisons Schedule Committee (NDPSC), will be replaced by the Secretary of the Department of Health or her delegate - who will be advised in deliberations by two new expert advisory committees - the Advisory Committee on Medicines Scheduling, and the Advisory Committee on Chemicals Scheduling. A single Secretariat will support both committees to “ensure ongoing consistency and cohesiveness of processes and decisions,” and the changes also include closer integration of the revised scheduling arrangements with existing Commonwealth evaluation and product registration schemes. The current Poisons Standard (SUSDB) will be renamed the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP), and the TGA also confirmed that cost recovery arrangements for scheduling are under consideration. “The changes aim to improve the efficiency and timeliness of scheduling decisions, while maintaining the existing high level of scheduling uniformity across Australian states and territories,” according to a statement on the TGA website.

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