Seeking input on the contestability of the efficacy assessment

Submissions are invited from interested stakeholders on a proposal for a pilot to determine the effectiveness of applicants providing complete efficacy assessments with submission of registration or variation applications (contestability of the efficacy assessment).

Background

Through the Efficiency though Contestability Programme, the Australian Government is assessing its functions to determine if performance can be improved through alternative structures, processes or provider arrangements. Contestability encourages Commonwealth entities to adopt a more commercial mindset and seek ways of improving the performance of existing or proposed government functions. Contestability shifts the emphasis from the function to be carried out to the desired outcome government seeks to achieve.

The APVMA proposes to trial a process to see if it’s possible to move the function of conducting or commissioning data assessments from the APVMA to the private sector while retaining the outcome of quality decisions for registration and variation applications.

Call for public comment

The APVMA is seeking feedback on all aspects the proposed pilot.

The consultation period is open until close of business on 1 February 2016. Following consideration of comments received during the consultation period the pilot proposal will be finalised and made available on the APVMA website by 30 June 2016.

Please send your written submission by email, post or fax to:

Efficacy Assessment Coordinator
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
KINGSTON ACT 2604

Fax: +61 2 6210 4776
Email: enquiries@apvma.gov.au

For enquiries, please call +61 2 6210 4778