EU DCP: International collaboration for the evaluation of generic drugs

The TGA has agreed, in principle, to participate in a pilot of the Decentralised Procedure (DCP) of the European Union, a collaboration on the evaluation of generic drug applications. Formal agreement to participate will be extended once we are assured that the pilot is covered under our regulatory information sharing and commercial in confidence arrangements with other regulators.

Under the pilot, an application for a 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.

The TGA maintains its commitment to its current high standards for assessing the quality, safety and efficacy of medicines. Under the pilot, medicines would only be approved for supply within Australia on the basis of a decision by a TGA delegate, and all medicine applications would continue to receive the same level of scrutiny by TGA evaluators.

Further information will be published on this important effort as it becomes available.