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Expedited Approval of FDA-approved Drugs in Australia: New Market Opportunities for Drugs and Devices

In the past, after gaining approval for a drug/device in the United States, subsequent approval in Australia involved significant duplicated effort and additional regulatory hurdles. This has resulted in a lack of incentive for pharmaceutical companies and delays of up to 2 years to bring some new drugs, generics, and devices to the Australian market.

New regulatory approval pathways being implemented by the Australian Government will allow for stronger reliance on FDA and/or European Medicines Agency (EMA) approval documents, thereby facilitating faster approvals of therapeutics, with less duplication of effort by Sponsors and the Therapeutic Goods Administration (TGA), Australia’s national regulatory body. With low submission fees relative to other geographic regions, faster approval times, and more effective use of foreign approval documents, the marketing of new drugs, devices, and generics in Australia is becoming a more attractive option for products already approved in the US or Europe.


In October 2014, the Australian government announced the Expert Panel Review of Medicines and Medical Devices Regulation. In 2015, the Expert Panel delivered two reports that considered the regulatory framework for registered medicines (drugs and biologics), medical devices, and listed medicines (dietary supplements) in Australia, and made 58 recommendations for reform. The recommendations are notably significant in terms of both scale and breadth of scope.

After targeted consultation with consumer, health professional, and industry groups, the Australian government released a response to the Expert Panel Review on 15 September 2016. In this response, the government welcomed the review, recognizing that streamlining access to new drugs and devices offers significant benefits for consumers, industry, and the TGA. The proposed reforms reflected the government’s plan to boost competitiveness and reduce unnecessary regulatory burdens.

The government accepted all of the recommendations related to the proposed regulatory framework for drugs, and all of the recommendations related to medical device regulation with the exception of a deferral of the recommendation to set up a registry for high-risk implantable devices for logistical reasons. The pharmaceutical industry has largely welcomed the recommendations.

The Australian government allocated over $USD15 million, in the last federal budget, in order to implement the reform measures to improve the regulation of therapeutic goods in Australia. The reforms will be progressively rolled out by the TGA over the next 18 to 24 months, with new regulatory pathways for some medicines already being put in place.

The Reforms

The major regulatory reforms include:

  • The introduction of new pathways for expedited and provisional approval of innovative and life-saving products (in line with regulatory pathways in other regions).
  • Faster Australian approvals for products that are already approved in the US and Europe, including new drugs, drugs approved via the 505(b)(2) pathway, generics, biologics, and devices, via greater reliance on foreign approval processes to reduce duplication of regulatory efforts. These reforms are expected to allow access to drugs and devices months to years earlier than the current system.
  • A risk-based approach to 505(b)(2)-equivalent approvals and variations to dietary supplements.

Approval of New Drugs (New Chemical Entities)

Pathway One: (the existing pathway) involves submission of a complete dossier for de novo assessment. Pathways Two and Three are the new pathways.

Pathway Two: submission of the NDA/dossier in standard CTD format, as submitted for a US/EU approval, an un-redacted evaluation report from a comparable foreign regulatory body, and an Australian specific (administrative) Module 1. The Sponsor should also provide justifications for any differences to the US/EU-approved drug and consideration of the data within the Australian context. The TGA’s abbreviated determination for approval will take into account the similarity of the approved US/foreign product to the proposed product, GMP certification of the manufacturer, any Australian context issues, and appropriate product labeling.

In the past, the closest equivalent of Pathway 2 required the submission of at least 2 foreign approval packages, along with additional TGA-specific requirements. This pathway was rarely used by Sponsors due to the higher regulatory burden in some cases than Pathway 1.

Pathway Three: Expedited approval, with data submission and assessments consistent with the requirements of Pathways One or Two.

Variations to Approved Drugs [505(b)(2)-type Determinations]

In cases where the product proposed for the Australian market differs in dosage form, strength, formulation, indication, or manufacturing process, the Sponsor will need to provide a justification of the potential impact on the quality, safety, or efficacy of the product. These determinations are similar to those performed in the US for products approved via the 505(b)(2) pathway or in Europe for the hybrid pathway. If the differences are minimal, and the product conforms with labeling requirements, the TGA can recommend the product for approval. If the differences have the potential to impact product quality, safety or efficacy, the Sponsor must address these differences such that the TGA can make an assessment based on the potential impact and the benefit:risk profile of the product.

Generics and Biosimilars

A similar Pathway 2 process involving submission of a US/EU ANDA application/dossier, one un-redacted foreign regulatory evaluation report, and an Australian specific Module 1 will be implemented for generics and biosimilars. However, the Australian government recognizes that the currently evolving pathways for biosimilars in other regulatory regions will delay the implementation of this pathway for biosimilars. A proposed generic can be recommended for approval if the US/EU Reference Listed Drug is sufficiently similar to the Australian reference product. Alternately, if there are differences in dosage form, strength, formulation, indication, or manufacturing process between the 2 reference products, the Sponsor can submit a justification for the differences in relation to their potential impacts on product quality, safety or efficacy of the proposed generic.

Cost Advantages

The new reforms will reduce time and regulatory efforts for pharmaceutical companies and device manufacturers considering bringing new products to Australia. This translates to financial incentives, specifically for products already approved in the US or EU. This is expected to achieve the Australian government’s desired effect of improving the availability of new products in the Australian market. The incentives for companies are in addition to existing generous R&D tax incentives for conducting clinical trials in Australia.

To learn more about the applicability of your product for approval in Australia, and the associated financial incentives of doing so, contact us.


Angela Drew, PhD
Product Ideation Consultant