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 that have happened over the last four years and their status.
TGA anticipated the completion of the remaining projects (with longer implementation timelines) by 30 June 2020, however, this has not been achieved as there has been a slowing in the implementation as globally, governments, the therapeutic goods sector and healthcare professionals respond to the pandemic.
The TGA is using the delay as an opportunity to undertake further consultation that will assist in developing more comprehensive guidance materials and refining implementation details relating to the reforms.
Prescription medicines regulatory reforms
| Reform | Description | Status |
|---|---|---|
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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 |
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New pathways that better utilise assessments from overseas regulators and work-sharing on joint evaluation reports |
Reform implemented |
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A new assessment pathway to allow certain promising new medicines to come to market up to two years sooner than standard processes. |
Reform implemented |
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Introduction of notification processes for certain low risk minor variations to registered medicines and biologicals. |
Reform implemented |
Medical devices regulatory reforms
| Reform | Description | Status |
|---|---|---|
|
Changes to ensure the regulation of medical devices aligns with European Union regulatory framework, where applicable. |
Partially implemented |
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Designation of conformity assessment bodies in Australia to undertake conformity assessment certification of medical devices. |
Partially implemented |
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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 |
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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 |
|---|---|---|
|
Data protection scheme for assessed listed medicines |
A data protection scheme for assessed listed medicines to be introduced to incentivise innovation within the Australian Complementary medicines sector. |
Final regulation amendments required |
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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 |
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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 |
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New assessment pathway for listed medicines (Assessed listed medicines) that may use 'intermediate level indications' following TGA assessment of efficacy evidence. |
Reform implemented |
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A single online database of approved ingredients for use in listed medicines is readily accessible to the public. |
Reform implemented |
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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 5 March 2021. |
Reform implemented |
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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 |
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There are now review and appeal rights for persons who apply to have a new ingredient permitted for use in listed medicines. |
Reform implemented |
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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 |
Removal of the pre-approval requirements for public advertisements of medicines, allowing the implementation of a more self-regulated model. |
Reform implemented |
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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. |
Partially implemented |
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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 |
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Comprehensive post-market monitoring scheme of complementary medicines |
The TGA now 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 |
|---|---|---|
|
The seven statutory advisory committees provide independent expert advice on specific scientific and technical matters. |
Reform implemented |
Further reviews
| Reform | Description | Status |
|---|---|---|
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A range of activities to streamline the regulation of low-risk products have been completed and work continues on the review of products classified as Class I medical devices immediately following inclusion. |
Ongoing review |
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Creation of a new Scheduling Policy Framework and Scheduling Handbook. |
Reform implemented |
Cross-cutting initiatives
| Reform | Description | Status |
|---|---|---|
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The SME Assist hub provides support services for small and medium sized enterprises navigating Australia's therapeutic goods obligations. |
Reform implemented |