Heads of Agency Meeting Summaries
Access Heads of Agencies Meeting – June 2026
At DIA Global in Philadelphia, the Access Heads of Agencies met (in person and virtually) to take stock of progress and momentum across the consortium.
Key takeaways for industry:
- Access continues to deliver against its GROWTH manifesto
- Momentum is building: Submissions to the New Active Substance Work Sharing Initiative continue to grow, with a 73 per cent increase in applications in 2025 compared to 2024 and a strong pipeline of Expressions of Interest ahead, including more 4 and 5-way submissions.
- Operational improvements underway: Recent cross-agency workshops are tackling practical challenges and strengthening the consistency and usability of work-sharing.
- Digital infrastructure advancing: Pilot testing of our new Trusted Regulatory Space, a secure platform to enable more efficient collaboration and information-sharing, will pilot later this year.
Expanding collaboration areas:
- Agencies are mapping alignment and differences to inform potential future work sharing pilots across the medicines life cycle.
- Work is underway to agree a process for handling enquiries to the Advanced Therapy Medicinal Products (ATMP) working group, with future plans to explore regulatory differences between consortium partners and learn from ATMPs already authorised via national routes.
What this means for industry:
Access is continuing to mature as a practical, multi-market pathway, with growing uptake, clearer processes, and new areas of collaboration emerging. Engagement from industry will be key to shaping its next phase.
Access Heads of Agency Meeting, 30 March 2026
Access Consortium sets 2026 priorities to strengthen work sharing and improve patient access to innovative medicines
The heads of the health product regulatory authorities from Australia, Canada, Singapore, Switzerland and the UK agreed on priorities to strengthen collaboration and improve regulatory efficiency at the Access Consortium Heads of Agencies meeting on 30 March 2026. This was the first Heads of Agencies meeting of the year and was chaired by the MHRA in its capacity as Access chair for 2026.
An action plan for the year was endorsed to support the GROWTH Manifesto agreed at the October 2025 meeting, with particular focus on enhancing work sharing processes.
Several ideas to improve work sharing will be taken forward, including a proposal to shorten response times to expressions of interest submitted to the consortium, and opportunities to streamline the review of applications. These efforts will support faster access to high quality, safe and effective medicines across member countries.
The Heads of Agencies noted plans to finalise the development of a shared, secure digital platform, to facilitate information-sharing and joint regulatory work among all five regulatory authorities.
And the Heads also agreed to adopt a strategic approach to communications and engagement, to ensure the Consortium presents a consistent, open and co-ordinated voice with industry and wider stakeholders.
Access Heads of Agency Meeting 21 October 2025
The Access Heads of Agencies met in person on 21 October 2025. Among other topics, the meeting focused on shaping the way forward for Access development, guided by the newly refreshed strategy.
The Access Heads of Agencies are pleased to share our renewed vision and commitment through our Access GROWTH Manifesto. This manifesto represents our collective aspiration to grow and advance regulatory cooperation to enable innovation, strengthen trust and accelerate access to safe, effective and high-quality health products to over 150 million patients across Access member countries. Through our shared commitment to GROWTH, we aim to transform and shape a harmonised, trusted, forward-looking and patient-centric global regulatory ecosystem through close engagement and collaboration with our stakeholders, positioning Access among the industry's preferred filing pathways.
The Access Consortium is reviewing existing initiatives and processes in light of both the strategic objectives set out in the 2025–2028 plan and this GROWTH Manifesto. This includes exploring opportunities to further enhance work-sharing and regulatory reliance procedures, strengthen engagement, and improve predictability for industry partners. As part of this process, the Access Consortium is working towards the development of a roadmap that will support more efficient collaborative review pathways and reinforce its value proposition for all stakeholders.