ORIGINAL - Medicines and medical devices regulation review

15 October 2018

On 15 September 2016 the Australian Government Response to the Review of Medicines and Medical Devices Regulation was released. It identified ways to improve access to therapeutic goods for consumers and remove unnecessary red-tape for industry whilst maintaining the safety of therapeutic goods in Australia.

An important focus of the reform program to date has been extensive consultation; internal, public and targeted. This will continue to be a priority and will help frame how we do things differently.

A range of improvements have already been implemented. Further enhancements to regulatory processes will continue to be implemented in a staged approach through to 2019.

A number of the reforms required changes to legislation. This large program of work was divided into two tranches; the first set of legislative changes was passed on 14 June 2017. These changes focused on new assessment pathways for medicines and medical devices. The second set of legislative changes was passed on 15 February 2018. These changes focused on a provisional approval pathway for prescription medicines and reforms to the regulation of therapeutic goods advertising and complementary medicines.


Medicines and medical devices regulation reforms

A number of reforms have now been implemented under the Government's Response to the Review of Medicines and Medical Devices Regulation which commenced September 2016, with further reforms in progress or upcoming.

Provisional approval pathway

The Provisional approval pathway allows sponsors to apply for time-limited provisional registration on the Australian Register of Therapeutic Goods (ARTG). It provides access to certain promising new medicines where the benefit of early availability of the medicine outweighs the risk inherent in the fact that additional data are still required.

SME Assist

Additional support to small and medium enterprises, and R&D groups developing new medicines and medical devices (including apps) understand their regulatory and legislative obligations with targeted tools and content

SAS Category C

Implementation of a notification scheme rather than pre-approval for supply of certain unapproved therapeutic goods to patients.

Authorised prescribers

A more streamlined application process to become an Authorised Prescriber of therapeutic goods.

Low risk minor variations to biologicals and registered medicines

A notification process for certain 'low risk' minor variations to registered medicines and biologicals, including implementation of a new e-form for prescription medicines.

Permissible ingredients

An updated catalogue of permissible ingredients for listed complementary medicines

Permitted indications

Establishment of a list of permitted indications for listed medicinal products from which sponsors must exclusively draw from when entering their product indications in the ARTG.

Assessed listed medicines pathway

A new pathway that allows the TGA to assess the efficacy of listed complementary medicines with higher-level indications that fall outside the permitted indications list.

Priority review pathway: prescription medicines

A priority review pathway that involves faster assessment of vital and life-saving prescription medicines for which a complete data dossier is available.

Priority review pathway: medical devices

A priority review pathway for either TGA conformity assessment, or inclusion in the ARTG of a medical device.

Pharmacovigilance and risk management

Introduction of the Pharmacovigilance Inspection Program to ensure medicine sponsors are meeting their pharmacovigilance and risk management requirements.

Adverse event reporting

The Black Triangle Scheme provides a way for practitioners and patients to identify certain new prescription medicines and encourage reporting of associated adverse events.

Advisory committees

Reduced number of advisory committees from eleven to seven with a new committee structure

Review and appeal rights

Review and appeal rights for assessment of new ingredients for use in listed complementary medicines

Comparable overseas regulators: prescription medicines

A registration process for prescription medicines involving the submission of unredacted evaluation reports from a comparable overseas regulator

Work-sharing arrangements with comparable overseas regulators for prescription medicines

Advertising reform

A single complaints handling function within TGA; a formal advertising compliance education program, clearer advertising requirements; enhanced sanctions and penalties; and the removal of pre-approvals for advertising.

SAS and AP applications

Online system to manage SAS and AP applications and notifications

Australian conformity assessment bodies

Designation of conformity assessment bodies in Australia to undertake medical device conformity assessment certification

Strengthening the assessment of medical devices

Harmonisation of medical device regulations with the recent changes to the European Union medical device regulatory framework, commencing with up-classification of surgical mesh from Class IIb to Class III and patient implant identification cards and information

Comparable overseas regulators: medical devices

Use of approvals from comparable overseas regulators to support inclusion of medical devices in the ARTG.


About the review

Terms of reference, panel, reports, discussion papers, questions and answers

Australian Government response to the review

Following consultation with stakeholders including consumers, healthcare professionals and industry, the government has supported the majority of the recommendations of the Review. Find more information in the documents below.

Prescription medicine regulatory reforms

The reforms will result in new medicines coming to market sooner in Australia, while maintaining a framework for safety, quality and efficacy

Medical device regulatory reforms

The reforms will provide earlier access to new medical devices for consumers and health professionals, and potentially reduce costs for industry

Complementary medicine regulatory reforms

The reforms will support consumer health decisions and improve transparency for industry and consumers

Simplifying regulatory arrangements for advertising of medicines and medical devices

The reforms will simplify the regulation of advertising therapeutic products to the public

Streamlined regulation of patient-specific access to therapeutic products

These reforms will see modifications to the Special Access Scheme (SAS)

TGA advisory committees

Efficiencies will be achieved through reducing the number of statutory advisory committees that provide independent expert advice to the TGA

Further reviews

The Expert Panel Review of Medicines and Medical Devices Regulation recommended that further reviews be undertaken

Reforms to the medicines regulatory framework

Questions and answers about the medicines regulatory reforms

Reforms to the medical devices regulatory framework

Questions and answers about the medical devices regulatory reforms

Reforms to the complementary medicines regulatory framework

Questions and answers about the complementary medicines regulatory reforms

Reforms to advertising of therapeutic products to the general public

Questions and answers about the advertising regulatory reforms

Reforms to patient-specific access to therapeutic products

Questions and answers about the patient-specific access regulatory reforms


Implementation of consultations

The table below shows when the TGA is expecting to release public consultation papers to enable stakeholder feedback on the implementation of the reforms. Public consultations will typically be open for a six week period. Because of the tight program for design of reforms it is not anticipated that extensions to consultation periods will be possible.

Targeted consultations are also being held to identify areas of regulatory burden that could be removed or business processes that could be streamlined.

The forecast shows anticipated public consultations commencing throughout 2018. 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.

Current and upcoming consultations

Consultation Timeframe for release of consultation document Status
Public consultation on proposal to transition to electronic Common Technical Document (eCTD) format for prescription medicine dossiers TBA Upcoming
Public consultation on proposal for the regulation of In vitro diagnostic (IVD) companion diagnostics TBA Upcoming
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 August 2017 Closed
Consultation on the draft therapeutic goods advertising code 2018 and associated guidelines March 2018 Closed
Complaints handling - Advertising of therapeutic goods to the public May 2018 Closed
Guidelines for advertisements for medicines containing Schedule 3 substances June 2018 Closed
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
Alignment with European medical device regulatory framework: Up-classification of surgical mesh & Patient implant cards July 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

Business processes to support complementary medicines assessment pathways including:

  • Evidence sources for de novo evaluation
  • Use of international evaluation reports
  • Assessment timeframes and fees
  • Enhanced post-market compliance monitoring
September 2017 Closed
Options for the implementation of a claimer for efficacy assessed non-prescription medicines May 2018 Closed
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