Implementation of reforms - public consultation forecast
Review of medicines and medical devices regulation
The table below shows when the TGA is expecting to release public consultation papers to enable stakeholder feedback on the implementation of the recommendations from the Expert Panel Review of Medicines and Medical Devices Regulation. Public consultations will typically be open for a six week period. Because of the tight program for design of reforms and potential development of amendments to legislation, it is not anticipated that extensions to consultation periods will be possible.
Targeted consultations will also be held with stakeholders to identify areas of regulatory burden that could be removed or business processes that could be streamlined to encourage innovation and improved patient access to products in the medicines and medical devices sector.
The forecast shows anticipated consultations commencing in the October 2016 - September 2017 period. 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 email@example.com.
|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||Open|
|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|
Recommendations to support use of new assessment and application pathways including:
|Streamlined regulation of patient-specific access to therapeutic products|
|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|