Access Consortium

AI Summary

The Access Consortium is a strategic coalition of five national regulatory authorities: Australia (TGA), Canada (Health Canada), Singapore (HSA), Switzerland (Swissmedic), and the United Kingdom (MHRA), which joined in October 2020. This document outlines the consortium’s framework for enhancing regulatory alignment and work-sharing to expedite patient access to safe, effective therapeutic products. Rather than focusing on specific company violations or individual inspection dates, the guidance details the consortium's operational structure and the 'Access Strategic Plan 2021-2024.' The regulatory framework centers on international cooperation to reduce duplication in technical assessments. Key initiatives include established working groups for New Active Substances, Generic Medicines, Biosimilars, and the newly formed Advanced Therapy Medicinal Products (ATMP) group. In November 2022, the consortium endorsed a statement on Good Manufacturing Practice (GMP) inspection reliance, further streamlining the oversight of manufacturing sites. For industry participants, the required actions involve utilizing the consortium's joint pipeline meetings to share information on new developments and submitting expressions of interest for work-sharing initiatives. These procedures allow for synchronized reviews across member jurisdictions, particularly for generic medicines and biosimilars. Companies are encouraged to contact the MHRA directly for queries regarding joint submissions. This collaborative model maximizes technical expertise and ensures a consistent approach to benefit-risk assessments on a global scale.