Access Generic Medicines Work-Sharing Initiative

The Therapeutic Goods Administration (TGA) Australia has released further information on the Generic Medicines Work-Sharing Initiative. It is an innovative work-sharing model for the coordinated assessment of generic applications filed with multiple Access Consortium agencies. The initiative has worked through the practicalities of undertaking a collective assessment that will complement the regulatory decision-making within each jurisdiction.

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

Access Generic Medicines work-sharing is actively exploring opportunities for work-sharing with the 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.
• Australia:,
• Canada:,
• Singapore:
• Switzerland:
• United Kingdom:

More details can be found on the related links below:
Access Generic Medicines work-sharing initiative | Therapeutic Goods Administration (TGA) []
Australia-Canada-Singapore-Switzerland-United Kingdom (Access) Consortium []


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