You are here

MMDR: Post-market monitoring reforms

14 November 2018

Reforms to the post-market monitoring of medicines and medical devices are being implemented in response to the recommendations arising from the Review of Medicines and Medical Devices Regulation.

The reforms will enhance monitoring and compliance of therapeutic products that are released to market.

Reforms that have been implemented

Pharmacovigilance and risk management

Introduction of the Pharmacovigilance Inspection Program to ensure medicine sponsors are meeting their pharmacovigilance and risk management requirements.

Adverse event reporting – Black Triangle Scheme

The Black Triangle Scheme has been introduced to provide a way for practitioners and patients to identify certain new prescription medicines and encourage reporting of associated adverse events.

Adverse Event Management System (AEMS)

The creation of a new electronic adverse events reporting system for medicines that allows efficient reporting of adverse events.

Reformatting product information

Changes to the format of the product information document to allow for the most important clinical information about a medicine to be upfront and easily accessible.

Further information

MMDR consultations

All consultations related to the Medicines and Medical Devices Regulation Review

Consultations related to post-market monitoring reforms

Up-to-date information about the reforms and their status.

Information on the Review of Medicines and Medical Devices Regulation, including links to the complete Review and the Australian Government's response.