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 [https://www.tga.gov.au/resources/resource/guidance/access-nas-work-sharing-initiative-qa].
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) [https://www.tga.gov.au/sites/default/files/2022-12/accs-operational-procedures-generic-work-sharing-initiative.pdf] 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) [https://www.tga.gov.au/sites/default/files/2022-12/accs-eoi-form-generic-work-sharing-initiative.pdf] 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: 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
More details can be found on the related links below:
Access Generic Medicines work-sharing initiative | Therapeutic Goods Administration (TGA) [https://www.tga.gov.au/access-generic-medicines-work-sharing-initiative]
Australia-Canada-Singapore-Switzerland-United Kingdom (Access) Consortium [https://www.tga.gov.au/international-activities/australia-canada-singapore-switzerland-united-kingdom-access-consortium]