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Australia Says No To ‘Complex’ US-Style Suffixes For Biologicals

 
• By Vibha Sharma

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.

Magnifying glass focusing on Australia
Australia Plans To Strengthen Adverse Event Reporting For Biologicals • Source: Shutterstock

Australia's Therapeutic Goods Administration has given up the idea of adopting the US approach of requiring sponsors to add four-digit suffixes to the non-proprietary name of biological medicines to support their unique identification. The agency is concerned that the US approach may result in unnecessary regulatory burden for sponsors and could also cause confusion.

Following an extensive consultation with stakeholders, the TGA is not making any changes to its current naming convention...

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