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Submissions received: Reforms to the generic medicine market authorisation process

17 December 2019

The TGA would like to thank respondents who provided submissions in response to the public consultation paper on reforms to the generic medicine market authorisation process.

A total of 23 submissions were received, which comprised:

  • 14 submissions from industry and regulatory consultants
  • 4 submissions from industry representative associations
  • 2 submissions from health professional representative groups
  • 1 submission from an international technical working group
  • 1 submission from an independent statutory authority
  • 1 submission from a consumer group

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



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  • Consultation submission: Juno Pharmaceuticals Pty Ltd








Outcome summary

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The public consultation sought feedback on whether changes to the requirements for demonstrating that Australian and overseas reference products are identical would reduce barriers for applicants seeking to register new generic medicines. It also requested information on any potential unintended consequences of changing these data requirements and suggestions on other ways that TGA could reduce barriers through increased international alignment.

There was support from the generic medicines industry for changes to requirements for demonstrating ‘identicality’ between overseas and Australian reference products. The suggested changes mainly focused on reducing Australian specific requirements and harmonising TGA approaches with comparable overseas regulators.

A general concern about possible effects on medicine quality and safety was raised by innovator companies and consumer groups. It was emphasised that safety and efficacy must not be compromised.


Changes to the requirements for demonstrating identicality between overseas and Australian reference products are being drafted. Noting the concerns raised, these changes will only apply to lower risk medicines under certain conditions. Current requirements for higher risk products will be maintained.

The public consultation asked if early advice from the TGA on biowaiver justifications would be useful in compiling a dossier to support an application for a new generic medicine. It sought suggestions for other ways that TGA could increase transparency and clarity of regulatory requirements for generic medicine applications.

Stakeholder comment

All submissions addressing this proposal were supportive of a formal process for requesting early advice for biowaiver justifications. Many respondents stated this could reduce product development costs and make the evaluation process more efficient. Many requested that the advice provided be binding and that the process be clearly and transparently defined. Many submissions also noted that it was appropriate that the process attracts a new fee.

Innovator and non-prescription medicine companies suggested that other application types and other technical issues could similarly be addressed prior to applications being lodged with the TGA.


Development of a new process for providing early advice will incorporate feedback on the need for a clear and transparent process, and the need for some legal basis to the advice. Amendments to the Therapeutic Goods Act 1989 (the Act) and the Therapeutic Goods Regulations 1990 will be needed to implement the new process. The new provisions in the Act will allow future expansion to allow advice on other technical issues and application types, addressing suggestions by innovator and non-prescription medicine companies.

The public consultation asked if adopting international templates would improve opportunities for joint submissions to multiple agencies and hence work sharing, and also sought other ways of improving the market authorisation process to support work sharing.

Stakeholder comment

There was some support for adopting international templates. It was noted that any changes should not result in increased regulatory burden and additional re-work of overseas dossiers submitted to TGA. Industry respondents stated that any changes should align with EU and ICH requirements and minimise or eliminate Australian specific requirements.

Overall, industry submissions stressed that the removal of Australian-specific requirements would best support international work-sharing activities.


Templates are being drafted for use by companies submitting applications to TGA. These templates will be based on international templates already adopted in Canada and Switzerland, addressing suggestions about reducing re-work of overseas dossiers.

The consultation presented two case studies of how incentives could be applied for generic medicines applications of special interest: 'first generics', to assist in reducing pressure on Pharmaceutical Benefits Scheme prices and expenditure; and 'prevention of medicine shortages', to increase the number of alternative sources of supply.

Stakeholder comment

There were mixed responses from industry to the proposal that the TGA should actively encourage applications for generic medicines by providing incentives. Some industry submissions stated that to do so was outside the TGA's remit, particularly in the context of prioritising to reduce government expenditure.

Many submissions acknowledged the problems identified in the two scenarios but noted that on-going supply would not be guaranteed by introduction of incentives. Most responses indicated that reducing Australian-specific requirements, faster processing of requests to vary manufacturers and a more efficient evaluation and approval process for all applications would all have a more significant effect on improving the supply of generic medicines in Australia.


In line with the stakeholder comment, we are not progressing with establishing incentives for first generics or for preventing medicine shortages at this time. Reforms to reduce Australian-specific requirements and create more efficient processes will be implemented in the first instance.

Some industry stakeholders raised the importance of quickly processing requests to vary existing medicines to address potential shortages. Any proposed reform to the variations process will take this into consideration.

Next steps

Targeted consultation is needed to confirm technical details on each of the projects that are being progressed. Some projects can be implemented after these details are confirmed, while projects requiring legislative reform have a longer implementation timeframe, dependent on parliamentary processes.