Australia’s regulatory body proposes transparency reforms

Home/Policies & Legislation | Posted 15/05/2020 post-comment0 Post your comment

Australia’s Therapeutic Goods Administration (TGA) has issued a number of proposed transparency reforms for feedback from industry stakeholders, including earlier notification of generics applications.

Data Transparency WPress V13c15

At present, the TGA only states it can ‘neither confirm nor deny’ receipt of an application.

In response to feedback from patients, carers and healthcare professionals that it is frustrating not knowing whether treatments are likely to be available in Australia, the TGA released a public consultation on whether they should start publishing information on medicines under evaluation [1]. This evaluation closed at the end of March 2019.

Now, the Administration has given approval to implement enhanced transparency measures and has published a paper to canvass opinion on different implementation options from industry stakeholders.

The proposals aim to increase public transparency about applications under evaluation, while also protecting the commercial value to the applicant. The TGA aims to do so by:

  • Only publishing information with the biggest impact on public health
  • Withholding information on generic medicines applications prior to registration
  • Providing the innovator company with earlier notification of generic medicines applications

The Administration outlines the proposed changes (which would require amendments to the 1989 Therapeutic Goods Act) in detail:

1) Early publication of major innovator medicine applications
Frome June 2020, the TGA could begin publishing earlier information on major innovator drugs accepted for evaluation, with details including the product sponsor, name, active ingredients and indications.

2) Earlier notification of generic medicine applications
The second proposed change relates to generic drugs; and is more complex. The TGA gives two different options for the implementation of this reform, which would begin from early 2021.

Early notification in addition to the existing scheme, only where a patent has not expired
Where the patent on the originator drug has not expired, the applicant would be required to notify the patent holder that their application has passed preliminary assessment.

This option would prevent the assessment of patent infringement claims being at the sole discretion of the applicant. It would also provide innovator manufacturers with the opportunity to resolve potential infringements before marketing; but does rely on the applicant on having ‘reasonable belief’ as to the existence of a patent. This means the patent holder might not always be notified of a generics application.

Early notification regardless of the existence of a patent
Under the alternative option, all generic drug applicants would be required to notify the innovator and the TGA, whether the patent has expired or not. Under this option, the TGA would not evaluate the generic medicine until the applicant notified the patent holder.

This option would provide more protection for the confidentiality and commercial value of a generic drug application and would mean the innovator is notified of all applications that rely on its information, whether or not the patent has expired.

However, it could impact the availability of generics applications by removing the option for applicants to avoid notifying the patent holder by declaring they are not infringing a patent, e.g. because marketing is not intended to start until after patent expiry.

The TGA is asking for feedback on these proposals from stakeholders, including what their preferred option is and the impact the different options might have on them, financial and otherwise.

Related articles
Australia approves five biosimilars since June 2019

Australia plans reform of its generics authorization process

Australia’s TGA will keep same names for biologicals

1. GaBI Online - Generics and Biosimilars Initiative. Australia’s TGA considering whether to publish drugs under evaluation []. Mol, Belgium: Pro Pharma Communications International; [cited 2020 May 15]. Available from:

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing. 

Copyright – Unless otherwise stated all contents of this website are © 2020 Pro Pharma Communications International. All Rights Reserved.

Source: TGA

comment icon Comments (0)
Post your comment
Related content
PDUFA VI: FDA could promote generics competition
47 MD001813
Home/Policies & Legislation Posted 29/07/2022
House bill passes FDA funding fees but conflicts with Senate bill
User Fee V13H23
Home/Policies & Legislation Posted 15/07/2022
US Senate clarifies status of interchangeable biosimilar exclusivity
Interchangeability V18K30
Home/Policies & Legislation Posted 27/05/2022
Nomenclature of biologicals and biosimilars in Peru
02 AA010638
Home/Policies & Legislation Posted 20/05/2022
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010