GMWSI Standards and Recommendations – Access Consortium

"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:

1. Scope: Products must be considered generics by all participating agencies, with all dosage forms eligible.
2. 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.
3. 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.
4. 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.
5. Round 2 Assessment: The RRA and CRAs assess responses to the consolidated LoQ for Modules 2–5 and share results.
6. Round 3 Assessment: The RRA finalizes the AR based on responses, with peer review by the CRAs.
7. 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