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Testing of biological medicines

V1.0 December 2015

22 December 2015

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Risk assessment

We apply a risk-based strategy that directs increased testing to high risk products, while allowing lower risk products to be tested either less frequently, or with less labour-intensive methods.

Risk assessment tool for biological medicines

To objectively assess the risk posed by a therapeutic good, we developed a risk assessment tool, which addresses the risks:

  • inherent in the product and its use (consequence)
  • posed by its manufacture, distribution and marketing (likelihood)

During development (and adaptation for biological medicines), the risk assessment tool was extensively and rigorously tested against a wide range of products which confirmed the process was objective, reliable and robust.

In addition, the risk assessment tool was reviewed by an external academic specialist, who found it 'comprehensive and well thought out'.

How the risk assessment tool works

The risk assessment tool assigns numerical weightings based on answers to relevant questions.

For example, as medicines in schedule 4 or 8 pose a greater risk to consumers, they have a higher weighting than those in schedules 2 or 3, which in turn have a higher weighting than unscheduled medicines.

The issues we examine are:

  • Risk to the consumer (scheduling)
  • Access to alternative medicines
  • Vulnerability of the patient population
  • Good manufacturing practice issues
  • Risk of route of administration
  • Adverse events, locally and overseas
  • Volume of product used
  • Testing failures, locally and overseas
  • Type of use (acute or chronic)
  • Possibility of counterfeiting
  • Complexity of product structure
  • Length of registration and product record
  • Complexity of manufacturing process and testing
  • Recalls of the product, locally and overseas
  • Stability of product
  • Issues raised by premarket evaluator(s)

Each of the issues has their own numerical weighting. Issues of consequence are added together, as are those for likelihood. The total values for consequence and likelihood are then multiplied to give a numerical risk factor, and from this, the product is allocated a calculated risk group.

Other factors we may consider

We may consider other mitigating or exacerbating factors, such as:

  • the corrective actions established by the sponsor
  • the severity or pervasiveness of reported adverse events
  • stakeholder sensitivity to adverse events.

These factors are recorded in both the review of the calculated risk group, and the final risk group.

Calculating testing intervals

The risk assessment tool uses the inherent risk of a product (consequence x likelihood scores) to calculate a testing interval, and a risk assessment interval (as illustrated by the fictitious ongoing monitoring example).

A table in the risk assessment tool is then used to record:

  • any reports of critical GMP deviations, testing failures, severe adverse event and recalls to be used in subsequent risk assessments, or
  • to explain the reason for any immediate risk assessment updates and/or actions taken in respect of any of these problems.

Example of the ongoing monitoring program calculations and records

This image represents a screenshot from TGA's risk assessment tool for biological medicines testing.

It is one of the final report screens which displays how frequently a biological medicine should be tested based on the information provided.

It displays the test group (product type) showing its final risk score (consequence of risk multiplied by likelihood of risk).

It then displays recommended testing intervals (in years) and risk assessment intervals (also in years). It shows the date these were last assessed, and when they are next due.

There is a field for further information, such as name of analyst, and action taken.

Screenshot described in text above

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