FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Stakeholders Prefer TGA’s Modified Approach to Naming Biologics Over FDA’s Suffixes

Jan. 30, 2018

An Australian Therapeutic Goods Administration proposal to expand the information offered in its current naming system for biologics drew support from most respondents, with Mylan warning an alternate proposal to adopt suffixes may offer little benefit for pharmacovigilance.

TGA sought feedback on several potential changes to its biologics nomenclature, included introducing suffixes to biological naming conventions, similar to the FDA’s approach, or introducing barcodes to allow traceability of batches, similar to the European Union’s practice.

Mylan Australia pushed back against the “misguided” belief that nomenclature changes will strengthen pharmacovigilance. “Such changes should only be implemented if there is clear evidence and expectation such would be the case,” the company wrote. Current pharmacovigilance practices are sufficient, and information allowing the tracing of medicines to a batch is already possible through the agency’s adverse event reporting system, Mylan said.

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