Access to unregistered drugs in Australia

15 August 2017 - Drugs can usually only be prescribed for patients if they have been approved by the Therapeutic ...

Read more →

TGA to be one-stop shop for complaints

10 July 2017 - The TGA will be given full responsibility over advertising complaints for medicines and medical devices in ...

Read more →

TGA to improve the handling of advertising complaints

10 July 2017 - Australia’s therapeutic goods regulator is implementing new arrangements to simplify and improve the handling of complaints about ...

Read more →

Call for inquiry into medical devices

5 July 2017 - The medical device industry is facing calls for a royal commission as a class action over vaginal ...

Read more →

Cost recovery implementation statement 2017-18

4 July 2017 - This Cost Recovery Implementation Statement provides information on how the TGA implements cost recovery activities associated with ...

Read more →

Authorised prescribers

3 July 2017 - The Government accepted the Expert Review of Medicines and Medical Devices Regulation recommendation to make changes ...

Read more →

Special Access Scheme

3 July 2017 - Introduction of category C pathway and new decision tool. ...

Read more →

J&J, Medtronic push back against TGA priority review proposal

21 June 2017 - Johnson & Johnson and Medtronic are pushing back against the Australian TGA’s proposed priority review pathway ...

Read more →

The medicines and health products that failed Therapeutic Goods Association testing

26 June 2017 - Dodgy vitamins, contaminated medicines, a flu vaccine that didn't work, ineffective hospital disinfectant and unreliable pregnancy ...

Read more →

Orphan drug program reforms

26 June 2017 - The objective of the orphan drug program is to provide an incentive to sponsors to bring ...

Read more →

Priority review pathway: prescription medicines

26 June 2017 - As part of the Government's response to the Review of Medicines and Medical Devices Regulation (MMDR review), ...

Read more →

Accelerated assessment of medical devices - priority review pathway

19 June 2017 - The TGA sought comments from interested parties on the consultation paper for accelerated assessment of medical devices ...

Read more →

Cannabis rules loosened after Senate gangs up on government

13 June 2017 - Terminally ill patients will get faster access to medicinal marijuana and be able to import their ...

Read more →

Reform of the Orphan Drug Program - transition arrangements

1 May 2017 - The Orphan Drug Program provides an incentive for sponsors to bring medicines for a small population to ...

Read more →

Changes to pharmaceutical extension of term application procedures the latest front in the battle for savings in Australia’s health care budget

26 April 2017 - It’s no secret that the Australian Government is struggling to manage the cost of its health ...

Read more →