Interested parties can comment on proposed changes to strengthen safety monitoring for medicines in Australia

The TGA has announced that it is introducing a range of changes to strengthen safety monitoring for Australian-registered medicines by enhancing the TGA’s post-market monitoring capability.

“We are undertaking extensive enhancement to the safety monitoring of medicines in Australia,” says the organisation in its consultation paper.

“The scope of our post-market monitoring activities extends across listed and registered complementary, over-the-counter and prescription medicines, as well as vaccines, biologicals and the different classes of medical devices.”

The changes will apply to medicines only and will be implemented progressively from late 2017 onward, says the TGA.

Enhancements will include:

  • A Black Triangle Scheme in order to alert health professionals and consumers that a particular medicine is newly available and to report adverse events associated with the medicine.
  • A Product Information (PI) reformat to ensure important prescribing information (such as indications, contra-indications, precautions and adverse event information) is easily accessible to the prescriber.
  • A pharmacovigilance (PV) inspection program, which requires sponsors of medicines to collect and report on relevant adverse events, and provide TGA with information on significant safety issues or any other information that is relevant to the balance of benefits and risks associated with their product.
  • Risk Management Plan (RMP) compliance monitoring to keep track of any changes to medicines that might introduce a new safety concern due to the addition of a new population group such as children or the elderly.
  • Improved collection and use of data to better support pharmacovigilance monitoring and compliance activities.
  • An Adverse Events Management System (ADRS), a new IT system that will replace the existing Adverse Drugs Reporting System (ADRS).
  • Improved international information sharing “to proactively minimise, detect and address medicine safety-related issues”.

Interested parties should respond by close of business Monday, 1 May 2017.

Click here to see the full consultation paper and to upload your submission.