Australian TGA proposes enhanced post-market monitoring

The Review of Medicines and Medical Devices Regulation (the MMDR review) has consulted on the strengthening monitoring of medicines in Australia.  A recently released presentation from the Therapeutics and Goods Administration (TGA) describes the current pharmacovigilance activities undertaken by the TGA and these will be strengthened and new activities will be introduced to improve the safety monitoring in Australia.

The new activities proposed are a Pharmacovigilance Inspection Programme (PVIP) and a Black Triangle Scheme (BTS).

The PVIP will be implemented on 1st September 2017 and the programme will apply to sponsors of prescription medicines, over-the-counter medicines and listed and registered complementary medicines.  Rather like GVP-related inspections conducted by other authorities such as the UK’s MHRA, TGA inspections priorities will be risk-based, however, the agency says that it may select sponsors for random inspections.  Where a sponsor is found to be non-compliant, the TGA begin by working with the company to help them address the issues.

The Black Triangle Scheme looks very similar to a scheme with the same name that has operated in the UK for many years.  Newly approved prescription medicines will have to carry the Black Triangle for a period of five years where there is a safety concern or missing information.  Provisionally approved medicines will be required to display the Black Triangle for the length of their provisional approval plus a further five years.

The Black Triangle will automatically end after five years for a product unless the TGA believes there are ongoing safety issues warranting retention of the symbol for a further period of time.  The Black Triangle symbol will be required to be displayed on the product information and consumer medicines information and at the time of removal, a sponsor will have to inform the TGA that they have removed the symbol.

The existing pharmacovigilance system in Australia will see enhancements generally commencing at the start of next year, in the areas of:

  • Risk Management Plan (RMP) Compliance Monitoring Program
  • Adverse Event Management System (AEMS)
  • Product Information (PI) Reformatting
  • Enhanced Collaboration with Overseas Regulators
  • Advanced Data Analytics.

More information on the changes can be accessed by clicking here.