Submissions received: Accelerated assessment of medical devices - Priority Review pathway

19 June 2017

The TGA would like to thank respondents who provided submissions in response to the November 2016 public consultation paper, Consultation: Accelerated assessment of medical devices – Priority Review pathway.

A total of 13 submissions were received. Of those submissions, 6 were from industry and regulatory consultants, 2 from industry representative groups, 3 from health professional groups and 2 from consumer groups.

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

Submissions

How to access a pdf document

*Large file warning: Attempting to open large files over the Internet within the browser window may cause problems. It is strongly recommended you download this document to your own computer and open it from there.

A I J MR

A

I

J

M

R

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 timeframes and publication for designation decisions and stakeholders sought further guidance on the proposed criteria.

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.

Further information on process details of the Priority Review pathway that has been informed by this consultation will be included in guidance documentation, to be released on the TGA website closer to the pathways' implementation date of 1 January 2018.

Outcome Summary

Table 1: Summary of changes to proposed resulting from public consultation: Accelerated assessment of medical devices – Priority Review pathway
Current situation Proposed implementation Benefits
Designation process

TGA has no formal mechanism for expedited applications for conformity assessment or ARTG inclusion.

Some comparable overseas regulators have an expedited process.

Applications for conformity assessment or ARTG inclusion are not published.

Two-step process to determine eligibility:

  • sponsor alert to TGA (minimum two weeks prior to application for Priority Review designation)
  • application for Priority Review designation (maximum four weeks from receipt by TGA to decision)

Designation decisions will lapse after six months.

Decisions on medical devices eligible for Priority Review designation will be published on the TGA website.

Clear and transparent process for determining eligibility.

Support accelerated assessment of novel devices for ARTG inclusion.

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

Criteria for Priority Review designation

No formal mechanism to determine if a medical device should be eligible for faster assessment by TGA

Eligibility criteria developed*.

The criteria are:

  • serious condition, AND
  • unmet need, AND
  • breakthrough technology AND/OR clinical advantage AND/OR public health (this optional only available for in vitro devices)

* High level descriptors for general communication

Ensures eligibility for medical devices providing the most benefit to patients.

Minimises the impact to business as usual by ensuring only eligible medical devices utilise the pathway.

Provides clarity to industry and health professionals.

Processing designated Priority Review applications

TGA processes for conformity assessment and ARTG inclusion do not have a formal mechanism for Priority Review

Faster processing of conformity assessment and/or ARTG inclusion through ‘front-of-queue' management of eligible medical devices designated for Priority Review.

A fee will apply to applications for designation, based on cost recovery arrangements.

Normal fees for conformity assessment and/or inclusion would also apply.

Early access to medical devices for patients.

Early access to market for industry, for eligible medical devices.

Clear process for industry.