Implementation of reforms - public consultation forecast

Review of medicines and medical devices regulation

11 August 2017

The table below shows when the TGA is expecting to release public consultation papers to enable stakeholder feedback on the implementation of the recommendations from the Expert Panel Review of Medicines and Medical Devices Regulation. Public consultations will typically be open for a six week period. Because of the tight program for design of reforms and potential development of amendments to legislation, it is not anticipated that extensions to consultation periods will be possible.

Targeted consultations will also be held with stakeholders to identify areas of regulatory burden that could be removed or business processes that could be streamlined to encourage innovation and improved patient access to products in the medicines and medical devices sector.

The forecast shows anticipated consultations commencing in the October 2016 - September 2017 period. The list will be updated periodically as consultation on additional areas of proposed reform commence.

You can subscribe to the TGA consultations email list to be notified when consultation documents are released.

For further information on the consultations please email mmdr.consultation@tga.gov.au.

Consultation forecast
Consultation Timeframe for release of consultation document Status
Prescription medicine regulatory reforms
Criteria for comparable overseas regulators - enhanced international collaboration in the regulation of prescription medicines October 2016 Closed
Expedited pathways for prescription medicines eligibility criteria and designation process October 2016 Closed
Provisional Approval pathway for prescription medicines March 2017 Closed
Strengthening monitoring of medicines in Australia: Enhanced medicines vigilance March 2017 Closed
Simplifying regulatory arrangements for advertising of medicines and medical devices
Consultation on options for handling complaints about therapeutic goods advertising and other changes to the advertising framework November 2016 Closed
Consultation on improvements to the Therapeutic Goods Advertising Code including a Proposed Framework for Schedule 3 Medicine Advertising September 2017 Upcoming
Monitoring and compliance of therapeutic goods
Enhancing sanctions and penalties in the Therapeutic Goods Act 1989 May 2017 Closed
Medical device regulatory reforms
Designation of Australian conformity assessment bodies for medical devices November 2016 Closed
Accelerated assessment of medical devices - priority review November 2016 Closed
Use of overseas regulatory approvals for medical devices and criteria for identifying comparable overseas designating authorities and regulators May 2017 Closed
Complementary medicine regulatory reforms

Reforms to the regulatory framework for complementary medicines:

  • Introduction of a new class of assessed complementary medicines
  • Mechanisms for establishing a list of permitted indications including the criteria for what a permitted indication is and the initial lists of permitted indications
  • Appropriate criteria for publication of claims on promotional material for complementary medicines
  • Incentives for encouraging innovation in the complementary medicines sector
February 2017 Closed

Recommendations to support use of new assessment and application pathways including:

  • Additional evidence sources for de novo evaluation
  • Use of international evaluation reports and
  • Assessment timeframes and fees
August 2017 (anticipated) Upcoming
Streamlined regulation of patient-specific access to therapeutic products

Changes to accessing unapproved therapeutic goods:

  • criteria for unapproved products of acceptable risk to be notified to TGA via SAS Cat B Scheme; and
  • a streamlined process for Authorised Prescriber Scheme applications
February 2017 Closed
Further reviews
The Scheduling Policy Framework and Advertising of Pharmacist-only medicines (Schedule 3 substances) March 2017 Closed
Options for the future regulation of 'low risk' products March 2017 Closed