Application profiling

The first step in this lower regulatory approach is to establish criteria and scope for lower regulatory intervention. Establishing the criteria includes examining:

  • what safety risks are associated with the application
  • how much information the APVMA already has about a particular product
  • whether there are alternative sources that allow the APVMA to satisfy statutory criteria.

Using the risk assessment framework developed by CEBRA the following elements have been identified as key to determining the level of regulatory intervention needed.

Elements that make up an application

 elements that make up an application

Each element contains several options to more clearly describe an individual application and combined, determines the level of regulatory intervention required.

For example, the ’label’ element has seven options:

  1. No change.
  2. New label new product meets standard.
  3. Notifiable variation.
  4. New label identical product.
  5. New label registered product.
  6. New label new product not previously seen by APVMA.
  7. Label not applicable for an active constituent application.

Each of the seven options above will flow into one of three levels of regulatory input for the ‘label’ application:

  1. None or not applicable and no label assessment required.
  2. Allowed variations which will be considered as a fast-track assessment.
  3. New assessment which requires a full consideration of the application.

Below is a description of how we expect some of these elements will work under the new approach.

The ‘product type’ element covers situations such as:

  • variations of an existing product
  • a new product, same as existing or completely new.

For agricultural products the intended ‘host’ and ‘pest’ elements will distinguish between an existing or new host/pest pair. Likewise, for veterinary products the ‘disease/condition’ element will distinguish between an existing or new host/disease condition pair.

This will then flow into an ‘animal/commodity’ type choice, where ‘animal’ refers to the species, subspecies, variant or race under consideration and the ‘commodity’ refers to the intended end use of the animal.

Again, the important distinction is between a new or an existing animal/commodity in a given context.

The ‘application method/dose administration’ element monitors any of the following changes:

  • dose or frequency of applications
  • season of application
  • interval between applications
  • method of application
  • administration route
  • booster regime.

For the ‘shelf life’ element, this is of importance for veterinary products.

The ‘manufacturer’ element can be new or existing, with an additional distinction between local and overseas manufacturers in the case of veterinary medicines.

At this stage, the application profiling is limited to identifying which applications lend themselves to being approved through a process of fast track assessment.

We expect to gradually roll these new approaches to application assessment out over the next two years.

Registration pathways

If a lower level of regulatory intervention is to be adopted by the APVMA, alternative pathways to achieve registration or consider variations must be made available. The APVMA has identified the following initiatives through which a lower level of regulatory intervention can be achieved:

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