“This document outlines the procedures for the Generic Medicines Work-Sharing Initiative (GMWSI) within the Access Consortium, including updates as of August 1, 2024. Key points include:
- Scope: Products must be considered generics by all participating agencies, with all dosage forms eligible.
- Application: Applicants must submit an Expression of Interest (EOI) to each agency three months before the expected submission. Applications must be submitted to at least two Consortium members simultaneously.
- Operational Approach: The work-sharing process follows each agency’s regulatory system, with timeframes adjusted for weekends or holidays. Pre-submission meetings, application acceptance, and timeframes are outlined.
- Round 1 Assessment: The Reference Regulatory Authority (RRA) evaluates Modules 2–5 and shares findings (Assessment Reports [AR] and List of Questions [LoQ]) with Concerned Regulatory Authorities (CRAs), who peer-review the results.
- Round 2 Assessment: The RRA and CRAs assess responses to the consolidated LoQ for Modules 2–5 and share results.
- Round 3 Assessment: The RRA finalizes the AR based on responses, with peer review by the CRAs.
- National Steps: Agencies finalize decisions, issue authorization letters, or request clarifications based on assessments.
Update: Appendix 1 and 2 now include details on the acceptance of foreign comparator products in bioequivalence studies for each Access Country.”
Source:https://www.tga.gov.au/news/news/access-generic-medicines-work-sharing-initiative-operational-procedures-update##~https://www.tga.gov.au/sites/default/files/2022-12/accs-operational-procedures-generic-work-sharing-initiative.pdf##~https://www.gov.uk/guidance/access-generic-medicines-work-sharing-initiative#full-publication-update-history##~https://assets.publishing.service.gov.uk/media/66a7a40c49b9c0597fdb066f/GMWSI_-_Operational_Procedures_v4.0.pdf
Region: Australia, Canada, Singapore, Switzerland, United Kingdom
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August 2024
