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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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Periodic risk assessments and changes to risk group

We initiate a risk assessment once the second round of evaluation is completed. For most biological medicines, the risk assessment results in full, grouped or protocol batch release.

We update the risk assessment once:

  • batch consistency is demonstrated
  • AND
  • the batch release period is ended by a change of conditions of registration, under section 28 of the Act

After demonstrating batch consistency, we generally assign products to the post-market monitoring program (risk group 5). From that time, we update the risk assessment on a regular basis (usually every three years).

Impact of significant or severe problems on the assigned risk group

We may review and update our risk assessment if there are local or overseas reports of significant or severe problems with:

  • GMP
  • adverse events
  • repeated testing failures and/or product recalls

Events that may result in a risk assessment review may include situations where there are reports of life threatening adverse events or immunogenic reactions.

Changes to risk group

If the risk assessment tool identifies a change in the risk of the product, this may trigger a recommendation to change the risk group.

We will consider any mitigating or exacerbating factors (in consultation with the sponsor), before assigning the product to an appropriate risk group.

If this risk group is different to the current risk group of the product, we will vary the conditions of registration (under section 28 of the Act) and inform the sponsor by email.

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