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Revised general requirements for tablets and capsules

Consultation

7 March 2008

This consultation closed on 7 March 2008.

Background

Therapeutic Goods Order No. 56 General standard for tablets, pills and capsules specifies the current Australian general requirements for these dosage forms.

TGO 56 was identified by the Therapeutic Goods Committee (TGC) (the expert committee established under regulation 34 of the Therapeutic Goods Regulations 1990 to advise the Minister on matters relating to standards for therapeutic goods) some time ago as having high priority for review in preparation for the proposed Australia New Zealand Therapeutic Products Authority (ANZTPA). Considerable work was undertaken by an expert advisory committee to develop a draft Order for the ANZTPA to specify general requirements for tablets and capsules. Although it had been intended that a draft Order would be released to stakeholders, the postponement of the establishment of the ANZTPA prevented this from occurring.

The TGC noted this situation at its November 2007 meeting and recommended that, despite postponement of the ANZTPA, there remained strong justification for updating the general requirements for tablets and capsules in Australia. The Committee therefore recommended that a draft new Therapeutic Goods Order should be released for stakeholder consultation and, as far as is consistent with existing therapeutic goods legislation, the draft Order should include the same technical requirements and be applicable to the equivalent medicines as proposed for the ANZTPA.

Proposal

It was proposed that Therapeutic Goods Order No. 78 General Requirements for Tablets and Capsules (TGO 78) will supersede TGO 56 as a standard made under section 10 of the Therapeutic Goods Act 1989.

You should note that, notwithstanding the proposal under the ANZTPA to broaden the definition of the default standard for medicines, current therapeutic goods legislation does not permit the option of multiple default standards. The British Pharmacopoeia is the default standard for medicines under current legislation.

TGO 78 (draft) incorporates an approximately two year transition period for products to comply with the revised requirements. This transition period would commence upon entry of TGO 78 onto the Federal Register of Legislative Instruments.

Rather than incorporate Supplementary Notes, it is proposed that TGO 78 would be accompanied by a guidance document providing explanatory information and a series of questions and answers relating to the practical application of the Order.

Consultation

Stakeholders were invited to provide comment on TGO 78 (draft) and its companion document Guidance on Therapeutic Goods Order No. 78 General Requirements for Tablets and Capsules, also in draft.

Information that would assist in the assessment of the regulatory impact of the proposal to update the general requirements for tablets and capsules is also being sought as part of this consultation process.

Comments received in response to this consultation were referred to the TGC for consideration.

Consultation documents

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