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Submissions received: Remaking Therapeutic Goods Order No. 78

23 July 2019

The TGA thanks respondents who provided submissions in response to the public consultation paper Remaking Therapeutic Goods Order No. 78 - Standard for Tablets and Capsules and reintroducing pills into the remade Order.

A total of 24 submissions were received, which comprised:

  • 4 submissions from government bodies
  • 14 submissions from industry sponsors, manufacturers and/or consultants
  • 4 submission from industry organisations
  • 1 submission from health professional body
  • 1 submission from consumer organisation

All submissions that gave permission to be published on the TGA website are available below in PDF format.

Submissions

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  • Consultation submission: Integria Healthcare

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Outcome summary

There was general support for the remaking of the order but divergent views on the proposed scope.

The majority of submissions expressed support for:

  • The proposal to expand the scope of the order to include pills (having been included in TGO 56 but omitted from TGO 78).
  • A transition period of 12 months for pills.
  • Recognition of multiple default standards and the option to use Australian-specific requirements, even where an applicable monograph is available.
  • Widening of the default content limits from 92.5-107.5% to 90-110% and for wider overages for vitamins and minerals to be applied to registered as well as listed medicines.

Feedback was sought on elemental impurity limits for herbal preparations and options for how this could be applied were included. A variety of views was offered, including support of the proposal, although one proposed option was noted to carry a risk of unnecessary regulatory burden. Other responses questioned the different approach taken for herbal medicines with respect to other medicines.

In response to submissions, the order was amended to allow herbal preparations not following an applicable monograph the option of adopting elemental impurity limits in either the USP dietary supplements chapter or the ICH requirements, consistent with recognising multiple default standards for all medicines.

Consultation feedback identified a need for a transition period for impurity limits in all medicines, and clarity on the requirement regarding safe levels. This was to allow manufacturing documentation to be updated. In response, a 2-year transition period was applied to all medicines for these requirements. Clarity on the need for consideration of safe levels of exposure to impurities, regardless of content in a particular batch of medicine, was provided in the guidance.

One submission questioned the exclusion of unapproved goods and information outlining the requirements for these goods has now been included in the guidance.

Further redrafting of the proposed order was undertaken to better clarify alignment between default standards and the Order. The draft was also amended in response to feedback that unintended changes had been made to dissolution requirements and to correct some minor typographical errors.

Next steps

The remade order Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019 came into effect in March 2019. Any feedback received post-implementation will be considered in the context of future revisions to the guidance or amendments to the order.