Regulation Impact Statement Updates

Official website for publishing regulatory impact analysis information for regulatory decisions announced by the Australian Government, COAG and COAG Councils.

Therapeutic Goods Order No. 78 – Standard for tablets and capsules

Aust Gov
5th July 2019

Remaking sunsetting instrument without significant amendments – Department of Health

On 21 March 2019, the Department of Health (the Department) remade the Therapeutic Good Order No. 78 (the Order) without significant amendment.

The remade Order, Therapeutic Goods (Standard for tablets, capsules and pills) Order 101, reflects changes made to the Therapeutic Goods Act 1989 since commencement of TGO 78 in 2009. It offers sponsors a choice to stay with existing requirements or to use requirements set out in an applicable monograph in the British Pharmacopeia (BP), the European Pharmacopoeia (EP) or the United States Pharmacopeia - National Formulary (USP).

Consistent with the intent of increasing international harmonisation, some active ingredient assay limits have been widened in the Australian-specific requirements that apply in the absence of an applicable monograph and certain internationally‑harmonised limits for impurities have been adopted.

Consistent with Government’s best practice regulation requirements for sunsetting instruments, the Department has assessed the Order as operating effectively and efficiently. Therefore, a Regulation Impact Statement is not required for remaking this instrument without significant amendments.

PDF icon Deputy Secretary Certification Letter544.16 KB

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