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Access Generic Medicines work-sharing initiative

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The Generic Medicines Work-Sharing Initiative is an innovative work-sharing model for the coordinated assessment of a generic applications that are filed with multiple Access Consortium agencies. The initiative has worked through the practicalities of undertaking a coordinated assessment that will complement the regulatory decision-making within each jurisdiction.

For more information about work-sharing and its benefits for sponsors, see Australia-Canada-Singapore-Switzerland-United Kingdom (Access) Consortium.

Generic Medicines approved through work-sharing

The TGA has approved the following medicines through the Generic Medicines Work-Sharing Initiative (as of 30 September 2023):

2023

  • dabigatran etexilate mesilate (DABIGATRAN SANDOZ)

2022

  • parecoxib sodium (PARECOXIB SANDOZ)
  • daptomycin (PFIZER DAPTOMYCIN)

2021

  • glatiramer acetate (GLATIRAMER VIATRIS)
  • pomalidomide (POMALIDOMIDE SANDOZ)

2020

  • fulvestrant (FULVESTRANT SANDOZ)
  • Posaconazole (POSACONAZOLE SANDOZ)

2017

  • everolimus (EVEROLIMUS-TEVA, TEVA-EVEROLIMUS)

How to submit an application for Generic Medicines work-sharing

Access Generic Medicines work-sharing is actively exploring opportunities for work-sharing with industry and is seeking applications for this initiative. Applicants who are interested in taking part in this initiative should:

  1. Review the Operational Procedures (OP) document below which outlines the operational steps, target milestones and recommendations for the planning and the filing of an application.
  2. Download and complete the Expression of Interest (EOI) form below to express interest in participating in a work-sharing submission
  3. Submit your completed EOI form to at least two of the Access Consortium members listed below via email. To be considered as a suitable candidate for this work-sharing initiative, submit your applications simultaneously to participating members.

Please include 'Access Consortium - Generic Medicines work-sharing' in the subject line of your email.

Related links

Australia-Canada-Singapore-Switzerland-United Kingdom (Access) Consortium
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