THE Therapeutic Goods Administration (TGA) has invited comment on a new consultation relating to 'Strengthening monitoring of medicines in Australia' - including the proposed introduction of a new Black Triangle Scheme to alert health professionals and consumers about newly available medicines.
One of the recommendations of the Medicines and Medical Devices Review was the improvement to the safety monitoring of medicines, with the proposal aiming to improve communication and collaboration, use of data and the collection of adverse events.
Black Triangle Schemes are already in use in the EU, with the symbol displayed on PI and CMI documents with an explanation that the product is subject to additional monitoring and a request to report suspected adverse events.
Other changes proposed include reformatting Product Information to ensure indications, precautions and adverse event information is easily accessible to prescribers.
The TGA's plans to enhance safety monitoring of medicines would take effect from late 2017 onward.
See tga.gov.au.
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