Regulators in the Access Consortium have introduced a common Promise pilot to align priority review decisions and timelines. The scheme, announced by the UK Medicines and Healthcare products Regulatory Agency on 15 December 2023 and updated through Operational Procedures v1.2 effective 1 June 2025, targets faster, near-simultaneous national outcomes with a published 180-day aim for priority files. (gov.uk)
The participating authorities are the Therapeutic Goods Administration (Australia), Health Canada, Singapore’s Health Sciences Authority, Swissmedic, and the UK MHRA. Under the work-sharing model, modules are divided among regulators for assessment while each agency retains responsibility for its national Module 1 and makes a sovereign licensing decision. (accessconsortium.info)
Eligibility is restricted to medicines for serious, life‑threatening or severely debilitating conditions where no other treatment is currently registered and marketed in participating jurisdictions for the proposed indication. The initial announcement focused on new active substances; the June 2025 procedures confirm eligibility also extends to new indication applications meeting the same test. The consortium indicates the pilot’s scope will be reviewed after the pilot phase. (gov.uk)
Timelines are front‑loaded. Sponsors should submit an Expression of Interest at least six months before filing; Access partners aim to acknowledge acceptance for the pilot around five months pre‑submission. A consolidated priority review request should follow three to four months before filing, with any clarification questions answered within two days and a priority decision targeted about two months before submission. (accessconsortium.info)
For the priority determination, applicants provide a single scientific justification and evidence package. One agency leads the appraisal and partners seek a consensus; if consensus is not reached, the sponsor may proceed under Promise with accepting agencies or use the standard Access procedure. The pilot confers no legal entitlement or appeal rights, and national fast‑track routes remain available. (accessconsortium.info)
On dossier submission, a 25‑day screening period precedes Day 0 acceptance across all participating regulators. During assessment, questions are typically issued on a rolling basis and sponsors are expected to respond within 15 calendar days; where agencies opt for a consolidated list of questions, the maximum response window is 30 days. (accessconsortium.info)
Formal work‑sharing concludes before national steps. Separate sovereign decisions are targeted for Day 180 under Promise, with agency‑specific processes-such as expert committee meetings and publication of public assessment reports-continuing to national timetables; for example, MHRA indicates publication within 60 days of approval or refusal. (accessconsortium.info)
Compared with the standard New Active Substance Work‑Sharing Initiative, which sets a Day‑300 target for national decisions, Promise compresses timelines significantly. The Access Consortium’s 2025–2028 Strategic Plan reiterates the 180‑day aim for the pilot against roughly 300 days for standard work‑sharing. (accessconsortium.info)
Operational expectations for sponsors include engaging at least two Access markets, aligning Modules 2–5 across dossiers with any differences documented via the consortium’s Summary of Differences table, using eCTD format, and scheduling a logistical pre‑submission teleconference about one month before filing. The same assessment pathway-standard or priority-must be used in every requested jurisdiction. (accessconsortium.info)