TGA joins international collaboration to evaluate generic drugs

The Therapeutic Goods Administration (TGA) has joined a pilot of the Decentralised Procedure (DCP) of the European Union - a collaboration on the evaluation of generic drug applications. The DCP is for applicants who wish to market a product in a number of EU member states at the same time when the product has not previously received authorisation in any EU member state.

Under the pilot, an application for marketing authorisation submitted in the framework of a DCP will be submitted concomitantly to the TGA. The objective of the pilot is to confirm that the sharing of this information can facilitate the marketing authorisation process by the participating non-EEA regulators. Medicines will continue to be approved for supply within Australia on the basis of a decision by a TGA delegate, and all medicine applications will continue to receive the same level of scrutiny by TGA evaluators. 

The TGA’s participation in the pilot offers applicants the potential to obtain market authorisation in a number of chosen markets as part of a coordinated process. Experience gained by industry and regulatory agencies will also help to inform other international information- and work-sharing models currently under consideration by the TGA and collaborating agencies.

The TGA encourages generic drug manufacturers to consider participating in the pilot. The expression of interest (EOI) form, available here, should be submitted by 10 October 2014.