Study pushes for greater adoption of a cloud-based regulatory environment
Broader adoption of cloud-based platforms by regulatory bodies could lead to significantly faster approval times, according to a study authored by Nina Cauchon of Amgen and colleagues published in the Journal of Pharmaceutical Sciences.
While advancements in pharmaceutical manufacturing are progressing swiftly, regulatory processes have not kept pace with the scientific innovations driving the use of these cloud-based solutions, the authors noted, adding that while advancements are being made in manufacturing and technical solutions to streamline information exchange between sponsoring companies and global health authorities, the regulatory environment is falling behind.
The authors highlighted a recent survey of pharmaceutical professionals by the International Society for Pharmaceutical Engineering. Out of 391 respondents, nearly half identified regulatory challenges as the main reason for hesitating to adopt new technologies. Their key concerns included a continued reliance on established regulatory frameworks that categorize novel approaches as higher risk, the lack of global consistency in regulatory requirements, and regulators' insufficient understanding of emerging technologies.
The authors note that “sponsors report that a novel manufacturing approach may be accepted by one health authority but delayed or rejected by others, leading to country-specific adaptations and requirements that strain resources and prolong approval timelines. These challenges are particularly pronounced for biologics and novel modalities, where even standard post-approval manufacturing changes may require years to secure approval across all markets.”
The recent introduction of new post-approval change (PAC) reliance pathways has facilitated work-sharing and transparency among multiple agencies, greatly improving the previous wave submission model. Additionally, a significant advancement in regulation is the use of cloud platforms that allow for real-time information exchange between pharmaceutical companies and various regulators at the same time.
The study cites numerous examples of recent post-approval chemistry, manufacturing, and controls (CMC) pilots “which show a dramatic advantage when reliance and cloud-based regulatory review are combined.”
For example, a Sanofi vaccine pilot tested whether a common variation package, shared questions and answers, could compress those timelines for a Type II CMC change when implemented in a cloud-based platform.
“The completed pilot showed that 55% of participating authorities concluded review within six months, 95% had approved within ten months, and all participating countries had approved the change within sixteen months.”
The Amgen Vectibix reliance and collaboration pilot to accelerate the review and approval of a post-approval change for a biologic also allowed the simultaneous submission of the core Common Technical Document (CTD) Module 3 dossier to the European Medicines Agency (EMA) and nearly two dozen participating countries. This submission was made available on the Accumulus platform, which provided regulators with real-time access to submission data, ongoing questions, sponsor responses, and updates throughout the review process. As a result, 85% of the participating authorities (23 out of 27) granted approval within nine months, compared to the typical approval timeline of approximately 36 months.
The study states that “taken together, these pilots are beginning to show how a single global CMC dossier can reduce redundant re-authoring, limit country-specific divergence, and support earlier implementation of supply-relevant manufacturing changes. Despite differences in design and orchestration, the pilots collectively showcase a pathway towards a faster, more collaborative decision-making process for managing post-approval changes.”
