Regulatory heads from Australia, Canada, Singapore, Switzerland and the United Kingdom met on 30 March 2026 for the Access Consortium’s first meeting of the year, chaired for the first time by the MHRA. They agreed priorities to strengthen collaboration and improve regulatory efficiency across the five authorities. (gov.uk)
The meeting endorsed a 2026 action plan aligned to the consortium’s GROWTH agenda, with a particular focus on enhancing work‑sharing procedures. In parallel, the five agencies are developing a shared, secure digital platform to support information exchange and joint regulatory work. (gov.uk)
The package is intended to shorten response times to expressions of interest and applications submitted via the Access pathway, supporting faster access to safe, effective and high‑quality products for patients in member countries. (gov.uk)
Partners also agreed a coordinated communications and engagement approach to present a consistent, open voice to industry and wider stakeholders. Agency heads endorsed early work towards a regulatory reliance approach for clinical trials and the creation of a new network for scientists involved in batch testing. (gov.uk)
The GROWTH framework sets six principles-governance, reliance, openness, work‑sharing, transformation and harmonisation-intended to build a trusted, patient‑centred model across five markets serving more than 150 million people. (accessconsortium.info)
Work‑sharing is established through collaborative procedures for new active substances and generic medicines, and sponsors can request joint pipeline meetings to shape viable submissions ahead of filing. In December 2023, Access introduced the Promise Pathway with a published 180‑day target turnaround, compared with 300 days under the new active substance initiative. (gov.uk)
Access materials describe the digital platform as a cloud‑based workspace enabling multiple regulators to conduct reviews in a common environment. Delivery is a central enabler of collaboration in the 2025–2028 plan and is expected to standardise document exchange and support more simultaneous assessments. (accessconsortium.info)
For sponsors planning 2026 submissions, practical effects should include earlier triage decisions on expressions of interest, clearer engagement routes, and stronger predictability on suitability for work‑sharing. Decisions remain sovereign: the consortium emphasises that collaborative assessments inform, but do not replace, national regulatory determinations. (gov.uk)
Policy Wire analysis: The proposed reliance approach for clinical trials will be pivotal to overall timings. Clear parameters on when one authority may draw on another’s assessment-alongside alignment with national ethics and data‑protection requirements-will determine the extent of any timetable compression. Publication of the platform specification and service standards for response times will be key early tests.
Background and track record: Established in 2007 as the ACSS group, the consortium added the UK in 2020 and moved to full work‑sharing participation from January 2021. Heads of agencies usually meet twice a year, and consortium data report aligned decisions on 26 new active substances and eight generics through work‑sharing to date. (gov.uk)