Australia Says No To ‘Complex’ US-Style Suffixes For Biologicals
Australia's Therapeutic Goods Administration wants to avoid the complexity and potential confusion associated with the introduction of a suffix-based system for naming biological medicines. The TGA has instead decided to supplement its existing naming convention for biologicals with a strengthened framework for reporting adverse events.
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Following a consultation with stakeholders, the Canadian regulator says identification of biologics using their brand and non-proprietary names has emerged as the most preferred option as it is consistent with current practice.
The Australian medicines agency has launched a public consultation on whether specific naming requirements should be applied to biologicals and their biosimilar versions. Among the options are the use of bar codes and suffixes to ensure individual products can be identified for traceability and pharmacovigilance purposes.
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