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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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Evaluations and initial risk groups

During the evaluation process, we assign your biological medicine to a risk group using the risk assessment tool.

Your application to register a new biological medicine is:

Variations to prescription medicines - excluding variations requiring evaluation of clinical or bioequivalence data: Process guidance outlines the normal Category 3 and self-assessable notification processes.

Impact of significant manufacturing changes on the assigned risk group

If you have a significant change in a manufacturing process, you are required to complete a comparability study before and after the change.

We will review the assigned risk group and notify you if any change is required, such as to:

  • the assigned risk group, which may increase if the risk level is increased
  • your release procedures, if the new risk group requires batch or protocol release

Changes to test methods or specifications

If you make changes to testing methods or specifications you will need to submit an updated copy of the Certified Product Details document to us.

Requirements for batch or protocol release

We assess the requirements for batch or protocol release testing during the evaluation process. The Delegate considers all recommendations and their suitability for inclusion in the approval letter.

Additional information which may be requested

If test methods used in the analysis of a new biological medicine are complex and approval seems imminent after the second round of evaluation, we may request:

  • a Certified Product Details (CPD) document
  • pre-registration samples, standards and consumables for method development

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