Access Generic Medicines work-sharing initiative
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:
- 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.
Access Consortium - Generics Operational Procedures (OP) [PDF, 181.05 KB]Access Consortium - Generics Operational Procedures (OP) [Word, 416.55 KB]
- Download and complete the Expression of Interest (EOI) form below to express interest in participating in a work-sharing submission
Access Consortium – Generics Expression Of Interest (EOI) Form [PDF, 284.28 KB]Access Consortium – Generics Expression Of Interest (EOI) Form [Word, 107.97 KB]
- 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.
- Australia: PCSInbox@tga.gov.au,
- Canada: BPS_Enquiries@canada.ca,
- Singapore: HSA_TP_Enquiry@hsa.gov.sg
- Switzerland: Networking@swissmedic.ch
- United Kingdom: access-mhra@mhra.gov.uk