Australia participating in EU DCP for evaluation of generic drugs

Under the auspices of the International Generic Drug Regulators Pilot (IGDRP), Australia’s Therapeutic Goods Administration (TGA) is participating in a pilot of the Decentralized Procedure (DCP) of the European Union, a collaboration on the evaluation of generic drug applications.

The objective of the pilot is to confirm that the sharing of this information can facilitate the marketing authorization process by the participating non-EEA [European Economic Area] regulators.

Under the pilot, an application for a marketing authorization submitted in the framework of a DCP will be submitted concomitantly to the TGA. 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.