速度可能误导：为何在全球化监管事务中速度最重要

Speed Can Mislead: WhyVelocity Matters Most in Global Table of contents Executive summary1 The problem: Faster submissions, more denials2Why speed-first AI falls short3Shifting the focus: From speedto velocity and patient-centricreasoning4What patient-centric AI reasoning really means4Embedding artificial intelligence into regulatoryactivities5Why patient-centric AI delivers better business outcomes5The future of AI in regulatoryaffairs6 Executive summary Artificial intelligence is changing how MedTech and Pharma organizationsmanage regulatory data, submissions, and compliance. The expectation is But in practice, speed alone doesn’t deliver better outcomes. Many organizations are moving faster, but not necessarily in the right direction.Submissions are increasing across global markets, yet a growing number aredelayed or rejected. Even when they are technically complete, issues such as That direction comes from context. It comes fromunderstanding how data connects, how evidencesupports claims, and how a submission will be evaluated The problem isn’t AI itself. It’s how it’s being used. When AI is focused primarily on speed and output, itcan introduce risk instead of reducing it. Errors getreplicated more quickly. Inconsistencies become harder Organizations that get this right don’t just move faster.They move more effectively. Submissions are strongerfrom the start, approvals are more predictable, and What actually matters is velocity. Not just speed, but Speed does not equal faster approval. When AI is optimized for throughput instead of contextual understanding,organizations move faster toward denials, rework, and The issue is not speed itself. It is the lack of direction The problem: Fastersubmissions, more denials When submissions do not fully reflect clinical andregulatory context, gaps start to show during review.Regulators are also using more advanced tools, which Regulatory teams are under increasing pressure to movefaster while managing more complexity than ever. Product lifecycles continue to shrink, and the nature ofregulatory data is evolving. Innovations like softwareas a medical device, real-world evidence, combination Problems that could have been addressed upfrontinstead appear all at once, leading to additional The pattern is becoming familiar: faster submissions, but To keep up, teams have turned to automation and AI. On the surface, that should help. In reality, the resultshave been mixed. Submissions are being completedfaster, but approvals are not necessarily following. In Organizations that invest in these capabilities operatevery differently. Instead of reacting to issues as theyappear, they anticipate them. Instead of moving quickly Embedding artificial intelligenceinto regulatoryactivities AI has the most impact when it is built into the wayregulatory work actually happens, not layered on top as Why patient-centric AI deliversbetter business outcomes In practice, that means embedding AI directly intoregulatory processes. Strong AI-enabled RIM solutionsdo more than process documents. They work within Organizations that take a patient-centric approach to AItend to see clear, measurable improvements. Submissions are accepted more often on the first pass.Review cycles become shorter, without sacrificingquality. The amount of rework and remediation drops, When this is done well, teams start to see issuesearlier. Potential objections can be identified beforesubmission. Deviations from prior approvals become Just as important, consistency starts to build trust. When submissions are clear, aligned, and supportedby strong data, regulators have more confidencein what they are reviewing. That translates into Over time, these systems get better. As they learn fromregulatory outcomes, they become more effective atidentifying patterns of risk and helping teams avoid Over time, this consistency pays off. Approvals becomemore predictable, and regulatory processes run with That said, AI does not replace regulatory expertise.The accountability for the accuracy and completenessof a regulatory submission still sits with regulatory The impact goes beyond operations. It directly affectspatients, who gain faster and more reliable access to A good example of where this matters is monitoringglobal regulatory changes and understanding theirimpact. This is only possible when the underlying data The executive reality... Faster submissions do not reduce Higher quality submissions do. That might include updating an in-flight submission,adjusting an approved product, or planning remediationactivities before issues arise. Without strong data CONTACT USeQMS@iqvia.comiqvia.com/smartsolvecompliance