Calls for additional labelling symbol on new medicines: NMS 2012

28 May 2012

Professor Emily Banks, Chairperson of the Advisory Committee on the Safety of Medicines (ACSOM) has called for better labelling for medicines which have been made available for use in the community but still require additional monitoring.

Speaking at the NPS National Medicines Symposium in Sydney last week, Professor Banks called for an additional symbol to be placed on a new medicine's packaging, advertising and other materials indicating that authorities are interested in gathering additional information on the medicine and inviting consumers to be a key part of this process.

Professor Banks said that under the Australian system, medicines undergo rigorous testing prior to being registered for use in the community.

“However, when medicines are first used, it is vital that we gather information about the experiences among people using it, particularly whether there are any unexpected adverse effects, outside the clinical trial setting,” she said.

Professor Banks says that this additional monitoring would complement the existing risk management framework of the Therapeutic Goods Administration, by allowing consumers to identify medicines are operating under a risk management plan. 

"A better risk communication system would help keep consumers better informed about the medicines they are using and encourage their participation in ensuring we can collect further information once the medicine is in use.

In announcing ‘TGA Reforms: A Blueprint for the Future of the TGA’ in December 2011, the Government agreed that the TGA should conduct, and report on, a feasibility study into the development of an early post marketing risk communication scheme for therapeutic goods, with consideration of international models.”

Similar programs are currently underway or planned in Europe.

Professor Banks says it’s important consumers remain at the centre of care when it comes to ensuring medicines are used safely and effectively in the community.

“This means providing consumers with the information they need to make the best decisions about their medicines. Providing people with a more complete picture about the ways of evaluating the risks of their medicines would help facilitate a better understanding of the processes that work to ensure we have safe medicines in Australia,” she said.

For a full copy of Professor Banks’ abstract, visit


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