Global Coordination: A Shared Priority
"To advance the field of exosome-based therapies, it is essential to standardise isolation and characterisation methodologies, deepen the understanding of exosome biology, and conduct rigorous clinical trials. Collaborative efforts with regulatory agencies are needed to establish clear guidelines that ensure safety and efficacy.
Exosomes Exposed Overview Systematic Review on Evidence Versus Expectation in Aesthetic and Regenerative Medicine. Rahman et al. (2024)
Bridging Innovation and Oversight
The exosome industry stands at a critical juncture where rapid growth has outpaced standardized oversight, creating significant challenges for regulatory bodies tasked with ensuring public safety. Recent research confirms that exosome therapy is in its infancy and the industry must address safety, efficacy, and regulatory issues to realize therapeutic potential. Current global regulatory approaches vary dramatically—with content-based regulation in some regions, production method-based oversight in others—creating fragmentation that complicates both compliance and enforcement.
EXACT™ OVERSIGHT BUREAU serves as a vital bridge between industry innovation and regulatory compliance, addressing critical gaps in current oversight. Research shows that exosomes are highly susceptible to degradation and alteration within a few hours after production, and that different methods can yield significantly varying results for particle size and concentration measurements. These quality control challenges, combined with product heterogeneity and batch-to-batch variability, highlight why existing GMP standards alone cannot ensure product efficacy and potency.
As an Independent Non-Profit Association (structured as a 501(c)(6) organization), EXACT™ maintains the credibility and independence essential for effective oversight. This structure ensures we operate as an industry-led initiative rather than a single company's tool, with founding companies serving as members but not owners of the organization. We collaborate directly with regulatory professionals to develop science-based protocols that align with FDA, ISO, ISEV, and international guidelines, offering independent third-party validation and auditing services that support regulatory decision-making. Our transparent reporting, standardized testing methodologies, and consensus-driven approach help regulatory bodies navigate these complexities while protecting consumers and advancing legitimate therapeutic applications.
Join Our Global Regulatory Initiative We invite regulatory professionals from all regions—including FDA/CBER, EMA, MHRA, TGA, ANVISA, PMDA, MFDS, and other national agencies—to engage with EXACT™ in developing harmonized oversight standards. Whether you're seeking collaboration on standards development, independent validation services, or insights into emerging industry challenges, we welcome the opportunity to support your regulatory mission. Contact us to explore how we can work together to establish the comprehensive oversight framework this rapidly evolving industry requires.