Supported by USD 19.1 million in funding from CEPI, the regulatory collaboration platform developed by global non-profit Accumulus Synergy, could enhance access to medical countermeasures by bolstering information equity. The platform seeks to enable regulatory authorities – responsible for approving new health products – to simultaneously review standardized, pertinent data on vaccine safety, efficacy and quality, allowing them to approve a health product based on that shared assessment – a process known as ‘reliance.’

A global regulatory preparedness framework

In pursuit of improving regulatory readiness and expediting vaccine authorization during public health emergencies, CEPI is building a global regulatory preparedness framework that leverages Accumulus’ platform for real-time collaboration and providing information equity that has been historically absent in many countries.

The COVID-19 pandemic highlighted the need for regulatory reform as access to essential health technologies in many cases was often delayed due to challenges within the existing regulatory system, including duplication of efforts, limited capacity and inequitable access to data required to approve medicines in Global South countries. All of these are underscored by the limited sharing of assessment reports between regulatory authorities.

“The CEPI-Accumulus partnership provides a unique solution to the challenges of pandemic preparedness by enabling seamless collaboration between regulatory authorities, industry stakeholders, and global health organisations across the world,” says Adam Hacker, Director and Global Head of Regulatory Affairs and Quality at CEPI. “The platform will be instrumental in managing disparate regulatory systems by streamlining and expediting access to crucial information needed to rapidly approve potentially lifesaving vaccines, helping us to stay ahead in the fight against pandemics.”

The project will start with a pilot of the platform with seven regulatory authorities to explore best practices to support vaccine developers in public health emergencies.

The CEPI-Accumulus partnership further enables the Accumulus platform to be available at little to no cost for regulatory authorities in Global South countries and increases access for developers in those countries and certain CEPI awardees, particularly in the case of a Public Health Emergency of International Concern. By equipping regulatory bodies in resource-limited settings with this cloud technology, this collaboration ensures that every nation, regardless of economic status, can contribute to and benefit from a unified global health response.

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Since launching at Davos in 2017, an Oslo-based global organization has been accelerating pandemic preparations. Years before COVID-19 appeared, the Coalition for Epidemic Preparedness Innovations (CEPI) began working to make vaccine development – including for coronaviruses – faster and less of a financial burden. CEPI is a global nonprofit, supported by public and private funders, […]


100 Days Mission

The project will start with a pilot of the platform with seven regulatory authorities to explore best practices to support vaccine developers in public health emergencies. The hope is that by bolstering regulatory preparedness now, when the next public health emergency strikes, the Accumulus platform will harness learnings from the preparedness phase to expedite approval and access to medical countermeasures during an emergency. This level of preparedness will support CEPI’s 100 Days Mission, a goal – embraced by leaders of the G7 and G20 – to deliver pandemic-beating vaccines in as little as 100 Days.