Powering Faster Multi-Agency Data Exchange
Nov 13, 2026 | Crystal Allard
Nov 13, 2026 | Crystal Allard
Global regulatory reliance speeds product approvals by eliminating the redundant, multi-year evaluation cycles that traditionally occur as a product moves through different jurisdictions. The World Health Organization (WHO) defines reliance as “the act whereby the national regulatory authority (NRA) in one jurisdiction may take into account and give significant weight to assessments performed by another national regulatory authority or trusted institution, or to any other authoritative information in reaching its own decision.” Critically, this is not a delegation of authority; the relying NRA remains “independent, responsible, and accountable regarding the decisions taken, even when it relies on the decisions and information of others.”
The four paths to regulatory approval
Identifying the appropriate reliance pathway and requirements is the first step in a global submission strategy. Understanding the various reliance models helps regulatory leaders anticipate efficiency gains and determine which reliance options are required vs. optional. While Veeva RIM supports all reliance pathways, some are administrative by nature while others benefit from shared submission platforms.
| Pathway Type | Core Focus | Target Timelines / Examples |
|---|---|---|
| Verification | Confirms identical product formulation and manufacturing sites to the reference approval; zero primary data reevaluation. | 30–60 days; Saudi SFDA fast-track, Singapore HSA verification route. |
| Abridged Review | Accepts reference assessments for baseline clinical safety/efficacy; evaluates local variables like stability and labeling. | 60–120 days; ASEAN harmonized pathways, GCC unified procedures. |
| Work-sharing | Features concurrent reviews of common dossiers with workloads split across technical sections. | Concurrent; The Access Consortium, Project Orbis (Oncology). |
| Transnational | Utilizes a unified technical committee to provide a single, centralized scientific review opinion for an entire region. | Standardized; EMA centralized procedure, WHO collaborative registration. |
Identifying the roadblocks: Why global approvals stall
Progress has recently been made in expanding reliance review using shared submission platforms such as Accumulus Technologies and DNAnexus’s Trusted Regulatory Spaces. The pace of innovation is increasing, but barriers remain:
- Regulatory silos and laws: Specific regional requirements force companies into redundant submission work. Policy changes are slow and not all allow the administrative use of reliance pathways or sharing of intellectual property. Health authorities tend to treat reliance like an administrative activity that requires manual coordination.
- Outdated technology: Regional technology disparities remain a hurdle. Data movement and use is more difficult when a relying agency uses legacy technology infrastructure. Security and data residency requirements can prevent data sharing.
- Data format inconsistencies: Discrepancies in clinical, product, and CMC data structures require manual rework for every new jurisdiction. Some health authorities are moving toward digital data formats while some are not.
- Regional submission formats: The continued dependence on non-eCTD formats and the administrative lift of certified local language translations create significant bottlenecks.
Under the current state of most sequential reviews, a product must be approved in a reference nation before the review clock begins in a relying nation. Financial implications aside, the cost of the status quo includes duplicated data analysis effort across health authorities and significant data storage and analysis costs. Transitioning away from sequential processes eliminates repetitive validation and review.
Enabling faster approvals with technology and collaboration
Despite the barriers, a path forward is emerging through converging digital standards and shared regulatory spaces.
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Shared collaborative platforms: Platforms like Accumulus and Trusted Regulatory Spaces are defining the new reliance paradigm. These shared submission platforms provide concurrent data viewing necessary for multi-agency review. |
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Digital standardization: The transition relies on the adoption of global standards with no regional requirements. New standards like ICH M16 and ICH M11 will work best with submission platforms. |
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Cross-sector partnerships: Success requires industry and government to define shared value. This is operationalized through tools like the Accumulus Connector, which integrates submissions in Veeva RIM with global health authorities in the Accumulus platform. |
Evidence of this shift can be found in recent high-impact pilots:
Recent high-impact regulatory reliance pilots
- Roche PAC Pilot (2024): Focused on Post-Approval Changes (PAC) in CMC, successfully proving that global approval timelines can be compressed through shared data access.
- Amgen Digital Dossier (2025): Utilized a CMC dossier with concurrent access for both reference and relying countries, effectively eliminating downstream sequential delays for critical drug changes.
Embracing a fully connected regulatory ecosystem will speed time-to-market, lower overall storage and validation costs, and improve real-time interagency dialogue. As simultaneous regulatory models take root worldwide, early adopters will define the future of global market leadership.
Learn more about Veeva’s commitment to global standards convergence and shared submissions platforms, see an Accumulus Connector for Veeva RIM demo, and hear from BeOne and Amgen about their experience using it.