Australia’s TGA considering whether to publish drugs under evaluation

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Australia’s regulatory agency, the Therapeutic Goods Agency (TGA) is consulting on whether it should publish that a prescription medicine is under evaluation.

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The consultation document was released for consultation on 15 February 2019 and interested parties had to respond by 29 March 2019.

Consultation: Whether the TGA should publish that a prescription medicine is under evaluation
Date: February 2019

The consultation came as part of the agency’s transparency reforms. Although it says that it currently consistently notifies the public once a medicine has been evaluated, this only happens following its registration. The agency is therefore considering four transparency options:

Option 1: maintain TGA’s current publication arrangements
Option 2: list all applications accepted for evaluation
Option 3: list all applications at two different time points
Option 4: list applications of innovator medicines of highest public interest, but not generic or biosimilar medicines

Option 1 keeps the agencies procedures as they are now.

Option 2 provides the greatest level of transparency and does not discriminate between applications for originator medicines, generics or biosimilars. Option 2 would also provide patentees with earlier warning of generics or biosimilars about to enter the market, and so facilitate the earlier resolution of pharmaceutical patent disputes in Australia, i.e. before the product is ready for launch, thus avoiding delays.

Options 3 and 4 on the other hand, will not facilitate the early resolution of pharmaceutical patent litigation and appears to have been included due to fears that Option 2 may discourage some early generics or biosimilars applications, due to the risk of infringement proceedings. However, this is the same risk that generics and biosimilars companies already face when their products are successfully registered on the Australian Register of Therapeutic Goods (ARTG) before patent expiry. The effect of earlier publication would only bring forward infringement proceedings and would not create new disputes.

Many other countries and regions around the world already publish all applications accepted for evaluation by their medicines agencies. This includes Europe, where the European Medicines Agency publishes a monthly list of all applications accepted by the agency, including generics [1] and biosimilars [2].

The consultation period for the TGA’s consultation has closed and the agency has not yet published its response.

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Biosimilars approved in Australia

1. GaBI Online - Generics and Biosimilars Initiative. Generics applications under review by EMA – January 2019 []. Mol, Belgium: Pro Pharma Communications International; [cited 2019 May 3]. Available from: 
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars applications under review by EMA – January 2019 []. Mol, Belgium: Pro Pharma Communications International; [cited 2019 May 3]. Available from:

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Source: TGA

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