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Overview of program status for the MMDR reforms

6 May 2020

The release of the Australian Government Response to the Review of Medicines and Medical Devices Regulation (MMDR) in September 2016, initiated a significant program of reform. The following tables provide information about the reforms and their status.

Prescription medicines regulatory reforms

Reform Description Status

Priority review pathway

New assessment pathway to allow for the faster assessment of vital and life-saving medicines. The target timeframe is up to three months shorter than standard processes.

Reform implemented

Comparable overseas regulators for prescription medicines

New pathways that better utilise assessments from overseas regulators and work-sharing on joint evaluation reports

Reform implemented

Provisional approval pathway

A new assessment pathway to allow certain promising new medicines to come to market up to two years sooner than standard processes.

Reform implemented

Variations to medicines through notifications

Introduction of notification processes for certain low risk minor variations to registered medicines and biologicals.

Reform implemented

Medical devices regulatory reforms

Reform Description Status

Aligning regulatory framework with the European Union

Changes to ensure the regulation of medical devices aligns with European Union regulatory framework, where applicable.

Ongoing alignment with the EU

Australian conformity assessment bodies

Designation of conformity assessment bodies in Australia to undertake conformity assessment certification of medical devices.

Partially implemented

Priority review designations

New approval pathway that allows for 'front-of-queue' assessment process. This includes processes associated with applications for conformity assessment and inclusion in the Australian Register of Therapeutic Goods for a medical device.

Reform implemented

Comparable overseas regulators: medical devices

New Pathways that utilise assessments from comparable overseas regulators to support the inclusion of medical devices in the Australian Register of Therapeutic Goods.

Reform implemented

Complementary medicine regulatory reforms

Reform Description Status

Comparable overseas bodies (COBs) for listed medicines

New pathways that allow applicants to use international evaluation reports from comparable bodies for the evaluation of registered complementary medicines, assessed listed medicines and substances for use as listed medicine ingredients

Reform implemented

Changes to the evaluation of substances for use in listed medicines

New application categories and legislated timeframes for the evaluation of substances for use as ingredients in listed medicines.

Reform implemented

Assessed listed medicines pathway

New assessment pathway for listed medicines (Assessed listed medicines) that may use 'intermediate level indications' following TGA assessment of efficacy evidence.

Reform implemented

Catalogue of permitted ingredients

A single online database of approved ingredients for use in listed medicines is readily accessible to the public.

Reform implemented

Permitted indications for use in listed medicines

All indications available for use in listed medicines are now contained in the Therapeutic Goods (Permissible Indications) Determination. Transition period for all listed medicines to comply with the new requirement ends 6 March 2021.

Reform implemented

TGA assessed claim for assessed listed and registered complementary medicines

The TGA assessed claim is a symbol and/or statement that indicates that a medicine has had the efficacy for its indications (a medicine's claimed purpose or health benefit) assessed by the TGA. It can only be used in assessed listed medicines and registered complementary medicines in accordance with the TGA's authority.

Reform implemented

Review and appeal rights

There are now review and appeal rights for persons who apply to have a new ingredient permitted for use in listed complementary medicines.

Reform implemented

Exclusive use of new ingredients

An exclusivity period to promote innovation and allow an applicant exclusive use of an approved new listed medicine ingredient for two years.

Reform implemented

Advertising reforms

Reform Description Status

Removal of advertising pre approvals

Transitioning public advertisements of medicines to a more self-regulated model from July 2020.

Transitioning to business as usual

Simplified arrangements for handling advertising complaints

The TGA is now the sole agency responsible for receiving and managing complaints about therapeutic goods advertisements.

The Advertising hub allows consumers to report illegal advertising.

Reform implemented

Enhanced post-market monitoring reforms

Reform Description Status

Comprehensive post-market monitoring scheme of medical devices

Continue implementation of a number of initiatives to enhance post-market monitoring of medical devices.

New electronic systems for medicines also support rapid adverse event reporting and improved pharmacovigilance analytics.

Ongoing implementation

Enhanced post-market monitoring of medicines

The Black Triangle Scheme alerts consumers and health practitioners of newly registered medicines and encourage reporting of any side effects.

New electronic systems for medicines also support rapid adverse event reporting and improved pharmacovigilance analytics.

Reformatted Product Information (PI) documents to make the most important clinical information about a medicine easily accessible.

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

Reform implemented

Comprehensive post-market monitoring scheme of complementary medicines

From December 2019, the TGA publishes the results of all our compliance reviews relating to safety and efficacy of listed medicines on the TGA website. Making information related to efficacy and safety publicly available will assist consumers to make informed choices regarding the appropriateness of listed medicines for them.

New electronic systems for medicines also support rapid adverse event reporting and improved pharmacovigilance analytics.

Reform implemented

Accessing unapproved products reforms

Reform Description Status

Changes to the Special Access Scheme (SAS) and the Authorised Prescriber Scheme (AP)

A notification pathway (Category C) to SAS allows approved health practitioners to supply certain products without seeking prior approval. The SAS and AP online system enables the electronic submission of SAS applications and notifications, and the submission of AP applications, to the TGA.

Reform implemented

TGA advisory committees reforms

Reform Description Status

Streamlined structure for statutory advisory committees

The seven statutory advisory committees provide independent expert advice on specific scientific and technical matters.

Reform implemented

Further reviews

Reform Description Status

The future regulation of low risk products

A range of activities to streamline the regulation of low-risk products, including the ongoing review of products classified as Class I medical devices immediately following inclusion.

Ongoing review

Scheduling policy framework

Creation of a new Scheduling Policy Framework and Scheduling Handbook.

Reform implemented

Cross-cutting initiatives

Reform Description Status

Support for small and medium enterprises

The SME Assist hub provides support services for small and medium sized enterprises navigating Australia's therapeutic goods obligations.

Reform implemented