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Submissions received: Expedited pathways for prescription medicines

17 March 2017

The TGA would like to thank respondents who provided submissions in response to the October 2016 public consultation paper, Consultation: Expedited pathways for prescription medicines - eligibility criteria and designation process.

A total of 33 submissions were received. Of those submissions, 17 were from industry and regulatory consultants, 2 from industry representative groups, 5 from health professional groups, 8 from consumer, academic and other professional representative groups and 1 individual.

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



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TGA response

Submissions received in response to the public consultation showed broad stakeholder support for the proposed approach. However, some modifications were proposed, particularly in relation to the eligibility criteria, timeframes for lapsing of the designation, and publication of designation decisions.

Stakeholder feedback has informed the policy position going forward and the upcoming changes to the Therapeutic Goods Regulations 1990. Policy changes resulting from the feedback are summarised in the Outcome Summary below.

Feedback has also been considered from an industry workshop and eight submissions received in response to targeted industry consultation on the Priority Review pathway which was conducted in late 2016.

Further information on process details of the Priority Review and Provisional Approval pathways that have been informed by this consultation will be included in guidance documentation, to be released on the TGA website closer to the pathways' respective implementation dates.

Outcome summary

Table 1: Summary of changes resulting from public consultation: Eligibility criteria and designation process for the expedited pathways for prescription medicines
Change Current situation Proposed change Benefits
Designation process

TGA has no formal mechanisms for expedited registration of prescription medicines - out of step with comparable overseas regulators.

Existing process for designation of orphan drugs - currently under revision

Applications for registration are not published.

Up-front process to determine eligibility for expedited pathways.

Designation decisions will lapse after six months.

Initially, positive decisions will be published on the TGA website at the time of designation, with additional information being published post-registration.

Clear and transparent process for determining eligibility.

Publication will provide useful information for patients, industry and health professionals.

Aligns with transparent designation processes of overseas regulators.

Eligibility criteria No formal mechanisms for determining which medicines should be eligible for faster assessment by the TGA.

Eligibility criteria developed, which are:

  • serious condition; and
  • major therapeutic advance, and
  • in comparison against existing therapeutic goods

Ensures that only medicines providing the most benefit to patients are eligible.

Minimise the impact on business as usual by ensuring that only eligible medicines are accepted into the pathway.

Provides clear expectation to industry.

Registration process Although some submissions have been processed more quickly in the past, the prescription medicines registration process does not have a formal mechanism for Priority Review.

Faster assessment through the use of more flexible business processes.

Exit criteria will be established to determine when Priority Review is no longer appropriate.

More resource intensive process will be cost recovered through new application and evaluation fees.

Early access to medicines for patients and early access to the market for industry.

Clear process for industry-provides more certainty.

Availability of process aligns with overseas regulators.