Access, new active substance and biosimilar work sharing initiatives

AI Summary

The UK Medicines and Healthcare products Regulatory Agency (MHRA), in coordination with the Access Consortium partners from Australia, Canada, Singapore, and Switzerland, utilizes the New Active Substance (NASWSI) and Biosimilar (BSWSI) Work Sharing Initiatives. This regulatory framework aims to streamline the approval process for innovative medicines by sharing technical assessments across international agencies. Between May 2022 and October 2025, various products achieved positive outcomes under this initiative, involving companies such as Roche (Vabysmo), Novartis (Scemblix), Vertex (Orkambi), and Sanofi (Dupixent). As this document is a procedural guidance rather than an enforcement report, it focuses on compliance requirements rather than violations. Key requirements for applicants include the submission of an Expression of Interest form three to six months prior to the planned application date. Applicants must provide identical electronic dossiers to all participating regulators to facilitate a joint review. While the consortium collaborates on evaluation reports and peer reviews, each national authority maintains independence regarding final marketing authorizations, product labelling, and the collection of national fees. This collaborative model ensures that safe and effective therapeutic products are made available to the public more efficiently through shared expertise and reduced administrative redundancy.