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Testing of biological medicines

Applicable to biological medicines, excluding vaccines, anti-venoms and toxins

19 July 2019

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Prioritising testing

Our testing program uses a risk-based strategy to prioritise testing. This allows us to focus on high risk products, while testing lower risk products less frequently, or with less labour-intensive methods. Products that have not yet established a track record of quality and safety, such as new products, and products associated with adverse drug reactions or manufacturing failures are considered high risk products.

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