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Focus: Further changes to the regulation of therapeutic goods in Australia

9 September 2009

In brief: The regulation of therapeutic goods in Australia has been changed following amendments to the Therapeutic Goods Act 1989. This is the second of three sets of amendments to the Act, with the last set yet to pass Parliament. Senior Associate Ric Morgan and Partner Sarah Matheson (view CV) report on the changes.

How does it affect you?

  • Each manufacturing site will need to be registered separately. Previously, subcontracted or distributed manufacturing was able to be conducted under a single licence.
  • TGA inspectors have greater powers during inspections of manufacturing sites.
  • All determinations of prohibited, allowable and controlled ingredients must now be legislative instruments, with the aim of increased transparency.
  • Homeopathic and anthroposophic medicines will fall under the common framework of medicine regulation.

Background

The Federal Parliament passed the Therapeutic Goods Amendment (2009 Measures No. 1) Act 2009 on 13 August 2009 and it received Royal Assent on 28 August 2009. This amends the Therapeutic Goods Act 1989 (Cth) (the TG Act) in a wide range of areas.

It follows the passing of the Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008 on 27 May this year, which received Royal Assent on 17 June. (See Focus: Changes to regulation of therapeutic goods, 23 June 2009.)

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Suspension of medicines from the ARTG for temporary safety issues

Previously, the only option where safety concerns arose regarding a medicine was the cancellation of the registration or listing of the medicine on the Australian Register of Therapeutic Goods (the ARTG). This imposes a significant regulatory burden and cost on sponsors, as they must apply for a new registration or listing. The Therapeutic Goods Administration (the TGA) now has more flexible options. The changes allow for the suspension of a registration or listing for a specified period of up to six months if it is likely that the problem will be able to be rectified within the period of suspension. This brings the options for medicines into line with the current options for medical devices. The suspension can have immediate effect where there is a potential risk of death, serious illness or serious injury.

Where there is no risk of death, serious illness or serious injury, immediate suspension is not permitted. However, the TGA may give notice of a suspension to take effect no earlier than 20 days after the notice. During the notice period (or, in the case of an immediate suspension, during the suspension), the sponsor has the opportunity to make submissions about the suspension.

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Manufacturing licences

Currently, a manufacturing licence, although limited to a 'premise', may cover more than one site. By the end of January 2010, each site will be required to have a manufacturing licence, unless a multi-site licence is permitted by a further legislative instrument. The Explanatory Memorandum makes it clear that multi-site licences will only be allowed where the multiple sites, while discrete, form part of a contiguous campus undertaking elements of the same manufacturing process.

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Inspection powers

The powers of inspectors at sites dealing with medicines or devices (including, but not limited to, manufacturing sites) have been expanded to allow the examination, measurement, testing, or taking of samples of anything at the site that relates to any therapeutic goods. It will also be possible for photographs and videos of the site to be taken.

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Homeopathic and anthroposophic medicines

Most homeopathic and anthroposophic medicines have been exempt from the requirements of the TG Act. The amendments bring such medicines within the TG Act and provide for standards to be applied to such medicines. These standards may draw on statements in publications nominated by the Minister for Health and Ageing in homeopathic pharmacopoeia or anthroposophic pharmacopoeia.

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Permitted ingredients

Previously, permitted ingredients for listed therapeutic goods were identified either by class or individually; however, there was no formal process for including ingredients. The changes introduce a formal process requiring the Minister to determine and vary permitted ingredients using legislative instruments. Further, no product will be listed unless it conforms with the relevant determined ingredients. A further effect of the change is to remove the ability to subject any determination by the Minister to administrative review.

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Further amendments likely

A further amending Bill relating to the regulation of therapeutic goods, the Therapeutic Goods Amendment (2009 Measures No 2) Bill, will make significant changes. In particular:

  • The scheduling (or classification according to risks to health) of drugs and other chemicals will be dealt with by separate expert committees and separate decision makers.
  • Costs recovery from manufacturers, importers and sponsors will be implemented.

In considering the Bill, the Senate Committee noted, with some concern, the limited nature of the Bill and the scope for further requirements to be imposed by determinations by the Minister and the Secretary of the Department of Health and Ageing. Submissions to the Committee made much of the lack of consultation and the lack of transparency of decision-making. Significantly, the Senate Committee's report on the Bill recommends that further efforts be made to consult with stakeholders in relation to the preparation of the relevant legislative instruments that will really regulate the scheduling of drugs and poisons.

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