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.
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- Outdated technology: Regional technology disparities remain a hurdle.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.
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.
