Published: 20 July 2015

Medicines

Changes to Priority Assessment Process

A priority assessment can be requested for a New Medicine Application (NMA) or a Changed Medicine Notification referred under section 24(5) of the Medicines Act 1981. There are three eligibility criteria for granting priority assessment.

• Significant clinical need.
• Significant cost savings.
• Medicines that are manufactured in New Zealand for export.

The intent of the priority assessment process is to undertake assessment in a reduced timeframe to facilitate patient access to the medicine. Products that are granted priority assessment become the next piece of work undertaken by the evaluator without negatively impacting on other deadlines.

For further information on the priority assessment process refer to the Guideline on the Regulation of Therapeutic Products in New Zealand.

What changes are being made?

With pharmaceutical companies increasingly turning towards the development of personalised medicines Medsafe has received an increased number of requests for priority assessment based on significant clinical need. Due to the number of applications that meet the criteria Medsafe has not been able to complete assessments in a reduced time.

Medsafe has determined that there is capacity for up to four NMAs with priority assessment, on the basis of significant clinical need, to be undergoing evaluation at any one time.

Requests for priority assessment on significant clinical need will now be based on two criteria:

• unmet clinical need
• resource capability.

Medsafe has reduced target timeframes for evaluation of additional information (EAI) for priority assessment and abbreviated NMAs. To continue to facilitate access to innovative medicines for the New Zealand public, this will be extended to NMAs that meet the clinical need criteria but there is insufficient resource for priority assessment of the initial evaluation. The reduced EAI timeframe is 28 days and will only be applied if a complete response to a request for further information is received within 28 days.

There are no changes being made to the priority criteria for significant cost savings or medicines that are manufactured in New Zealand for export.

These changes come into effect immediately.