Update: EU DCP: International collaboration for the evaluation of generic drugs

8 September 2014

Under the auspices of the International Generic Drug Regulators Pilot (IGDRP), the TGA is participating in a pilot of the Decentralised 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 authorisation process by the participating non-EEA regulators.

Under the pilot, an application for a marketing authorisation 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.

Our 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.

Expression of Interest for generic drug applicants

The TGA encourages generic drug manufacturers to consider participating in this ground-breaking pilot. The Expression of Interest (EOI) can be downloaded.

How to access a Word document

Responses to this EOI are requested by 10 October, 2014.

The enclosed EOI provides operational details for the pilot including:

  1. List of eligibility criteria.
  2. EOI request form to participate in the pilot. The form includes a section seeking consent from sponsors for the EU DCP to share assessment reports with pilot participants and other IGDRP member agencies of the sponsor's choosing in real time.
  3. Contact information at participating regulatory agencies.
  4. Summary of Quality Differences form.

Please forward the enclosed EOI to the contact points for each selected agency in your EOI. The contact for TGA is PCSInbox@tga.gov.au. Applicants should also inform the proposed Reference Member State (RMS) of the EU DCP and the CMDh-Member of this member state about the intention to participate in this pilot program.