TGA List Out Comparable Overseas Bodies (COBs) For Complementary Medicines

The TGA makes use of assessments from comparable overseas bodies (COBs), where possible, in evaluations for complementary medicines and listed OTC medicines. COBs in the European Union and US are among the organizations to have met the criteria established by TGA.

In response to the Medicines and Medical Devices Review, TGA moved to help companies use COB assessments in their filings to sell complementary and listed OTC medicines in Australia. That effort by TGA has now manifested in criteria for determining whether an overseas body is comparable and an initial list of organizations that make the grade.

The TGA will consider evaluation reports from the bodies specified for use in the COB report-based process. This list has been determined by the Secretary for the purposes of regulation 16GJ of the Therapeutic Goods Regulations 1990.

TGA will allow companies to use certain evaluations from the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) to inform its assessments of the safety, quality and efficacy of their products. The TGA criteria permit the use of reports from other agencies in one or two of those areas, but only evaluations from EMA and FDA can inform safety, quality and efficacy.

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