Australia's TGA consults on requirements for the Rx medicine streamlined submission process

Australia's Therapeutic Goods Administration has completed a review of the prescription medicine evaluation process, with a number of areas for streamlining being identified. Prior to implementation of the new streamlined process the TGA is inviting external stakeholders to review the proposed changes and provide comment on the underlying requirements that have been developed to underpin the process.

In the modern regulatory environment health regulators around the world, such as the TGA, are being asked for greater transparency in their regulatory processes, earlier access to novel therapies and more cost effective regulatory processes. Mindful of these sometimes competing demands, the TGA says it is progressing the prescription medicines Business Process Reforms (BPR).

The TGA notes that, currently, it takes on average approximately 500 days for a new prescription medicine to be approved by the agency. The BPR has identified a number of areas for process improvement to reduce this time significantly, to around 300 days. This will be achieved by eliminating unnecessary queues and delays in the evaluation process that have developed over time. It is important to note that this can be achieved without compromising the scientific rigor of the evaluation process; ensuring appropriate standards of quality, safety and effectiveness are maintained, the TGA stressed.