The five countries are working together to improve access to innovative medical products.
The Access Consortium, a coalition of the regulatory authorities from Australia, the UK, Canada, Switzerland and Singapore, has released its strategic plan for the next three years, including a new cloud-based workspace to facilitate joint reviews.
Australia’s Therapeutic Goods Administration, Health Canada, the Health Sciences Authority of Singapore and Swissmedic formed the original alliance in 2007. The UK’s Medicines and Healthcare products Regulatory Agency joined up in October 2020.
The heads of the five agencies meet twice annually face-to-face and also via teleconferences to review progress of the Access Consortium working groups and approve the work program for the upcoming year.
Access offers joint pipeline meetings to pharmaceutical companies and biotechs to exchange information and help plan work-share applications for biosimilars, advanced therapy medicinal products, generic developments for complex technologies, and new active substance candidates for standard or priority review.
The new strategic plan, published earlier this week, details the Access Consortium’s goal to “provide faster access to safe, effective and high-quality medicines” via “work-sharing and regulatory collaborations”.
The new cloud-based platform, described by the authors of the plan as a “first-of-its-kind collaboration”, will allow multiple regulators to conduct reviews in a joint environment, with a view to facilitating “a faster, more collaborative review process”.
“Access is committed to maximising collaboration by aligning regulatory and policy approaches; reducing duplication of regulatory reviews; streamlining and transforming regulatory processes; and, serving as a ‘testing ground’ for innovative collaborative approaches and acting as a pilot group for larger international initiatives,” said the plan.
The consortium’s “Access Promise Pathway” offers aligned priority review for lifesaving medicines within a shorter published target turnaround time of 180 days compared to 300 days.
The strategic plan outlines four objectives for the consortium for the next four years, including:
- Strengthening access work-sharing initiatives, including greater alignment of regulatory approaches and technical and scientific requirements;
- Expanding lifecycle approach, including strengthening collaboration and scientific information sharing on pharmacovigilance, post-market safety and risk management plans;
- Supporting regulatory innovation, including leveraging joint pipeline meetings to support innovative products; and,
- Enhancing engagement, including developing and implementing an effective communication strategy to stakeholders.
Read the full strategic plan here.
