An important focus of the reform program is stakeholder consultation to inform how we put in place the reforms. It is important that we understand how the changes we make may impact stakeholders.
Stakeholders will have the opportunity to give feedback on how to best to implement the reforms. Public consultation papers will be released for different projects at different times. Typically, public consultations are open for a six week period. Targeted stakeholder consultations are also occurring to identify areas of business processes which could be streamlined or refined.
You can subscribe to the TGA consultations email list to be notified when consultation documents are released.
Consultations related to the reform program are listed below.
Prescription medicines regulatory reforms
- Criteria for comparable overseas regulators - enhanced international collaboration in the regulation of prescription medicines
- Expedited pathways for prescription medicines eligibility criteria and designation process
- Provisional Approval pathway for prescription medicines
Medical devices regulatory reforms
- Designation of Australian conformity assessment bodies for medical devices
- Accelerated assessment of medical devices - priority review
- Use of overseas regulatory approvals for medical devices and criteria for identifying comparable overseas designating authorities and regulators
- Alignment with European medical device regulatory framework: Up-classification of surgical mesh & Patient implant cards
Complementary medicines regulatory reforms
- Options for the implementation of a claimer for efficacy assessed non-prescription medicines
- Reforms to the regulatory framework for complementary medicines
- Business processes to support complementary medicines assessment pathways
Reforms to the advertising of medicines and medical devices
- Proposed therapeutic goods advertising code guidance
- Guidelines for advertisements for medicines containing Schedule 3 substances
- Consultation on the draft therapeutic goods advertising code 2018 and associated guidelines
- Complaints handling - Advertising of therapeutic goods to the public
- Consultation on improvements to the Therapeutic Goods Advertising Code including a Proposed Framework for Schedule 3 Medicine Advertising
- Consultation on options for handling complaints about therapeutic goods advertising and other changes to the advertising framework
Monitoring and compliance of therapeutic goods
- Enhancing sanctions and penalties in the Therapeutic Goods Act 1989
- Strengthening monitoring of medicines in Australia: Enhanced medicines vigilance
Streamlined regulation of patient-specific access to therapeutic products
- Changes to accessing unapproved therapeutic goods through the Authorised Prescriber (AP) and Special Access Schemes (SAS)