Australia, New Zealand Propose Parallel Drug and Device Monitoring System
Posted 08 March 2013 | By
In the latest collaboration since Australia's Therapeutic Goods Administration (TGA) and New Zealand's Medsafe agreed in 2011 to proceed with a joint scheme for the regulation of therapeutic products, the two agencies have jointly opened a consultation on a proposed parallel process for an early warning system concerning the safety of medicines and medical devices.
Each regulatory agency would identify drugs and devices with potential safety concerns through their existing post-marketing monitoring system and then share that information.
The proposed process would involve the issuance, when necessary, of safety communications in the course of each agency's therapeutic vigilance system. The proposal does not recommend the creation of a single integrated early warning system, although this may be considered at a future date.
The communications would be of two types: monitoring communications and alert communications:
Monitoring communications are intended to highlight potential safety concerns, stimulate adverse event reporting, and instruct users to follow the manufacturer's product information and instructions for the product. The decision to issue a monitoring communication can be made either at the initial assessment/risk analysis step when all safety concerns are being considered, or the signal investigation/assessment step when concerns deemed to be safety signals are considered. All monitoring communications will be followed up with a communication advising the outcome of the safety concern.
The decision to issue an alert communication is made at the conclusion of the signal investigation/assessment and is made independent of whether a monitoring communication was issued or not. The aim of the alert communication is to provide important information and recommendations about therapeutic products, including where the TGA/Medsafe has investigated a safety concern and whether any actions are required.
Medsafe has already tested on a trial basis an early communication system called M2. Information from this trial indicates that the publication of early communications can stimulate further reporting of adverse events. Actions have been taken as a result of these simulated reports to improve medical product safety. For other concerns, which did not receive further reports, the lack of new reports assisted Medsafe's decision not to investigate the concern further.
The deadline for comments on the consultation is 7 April 2013.