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.
Changes delivered so far
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.
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.
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.
An updated catalogue of permissible ingredients for listed complementary medicines
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.
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
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
The Expert Panel Review of Medicines and Medical Devices Regulation recommended that further reviews be undertaken
Questions and answers
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