Resilience management in clinical trial supply chains
Navigate tariffs and geopolitical disruption without jeopardizing first patient in, patient safety or trial integrity
Recent tariff developments and evolving policy proposals may materially affect clinical trial supply chains—especially global investigational medicinal product (IMP) networks. Even where pharmaceutical exemptions exist, exposure persists through nonexempt inputs, policy uncertainty and indirect capacity/lead-time shocks. Four key challenges call for a new strategic framework to supply chain resiliency.
Key Takeaways
- Clinical trials changes often require regulatory notifications and review periods, limiting speed to response.
- More than 65% of global active pharmaceutical ingredients (APIs) are manufactured in China and India.1
- The minimum review period the Food and Drug Administration (FDA) requires for many manufacturing changes is 30 days (potentially 60 to 120 days for complex modifications).2
Why building resilience is now critical
Clinical trials can’t pivot like commercial supply chains can. Changes often require regulatory notifications and review periods, limiting speed to response. Concentration risk is structural. With more than 65% of global APIs manufactured in China and India, sponsors face portfoliowide exposure via shared contract manufacturing organization (CMO) infrastructure.3
Where exposure remains (even with exemptions)
While current tariffs include exemptions for many pharmaceutical products from these regions, clinical trial supply chains remain exposed through:
- Nonexempt materials such as excipients, packaging components, and manufacturing equipment
- Evolving policy landscapes that create planning uncertainty
- Indirect impacts from supply chain reconfigurations affecting capacity and lead times
Why clinical trials are uniquely exposed
- Fixed budgets, no cost pass-through: Budgets are locked at protocol development.
- Specialized, low-volume production: Per-unit tariff impacts can be disproportionate.
- Temperature sensitivity: Customs delays and rerouting can threaten product integrity.
- Extended regulatory response time: Supplier and manufacturing changes can take months, not weeks.
- Patient safety imperatives: Delays can cascade into missed dosing windows and protocol deviations.
The key challenge for clinical supply chains
Unlike most standard commercial operations, clinical supply chains cannot rely on buffer inventory or rapid alternate sourcing without regulatory friction. This means disruptions can directly threaten first patient in (FPI), trial timelines and patient access.
Final Summary
Trial sponsors that act decisively to build resilient clinical supply networks can:
- Protect development timelines and reduce FPI risk
- Maintain uninterrupted patient access to investigational therapies
- Mitigate direct and indirect cost/compliance pitfalls
Ready to turn volatility toward sustainable competitive advantage while upholding patient obligations?.
Discover a strategic framework for resilience with outlined capabilities in our full “Building resilience in clinical trial supply chains” report.
Endnotes
- Joanne S. Eglovitch, “USP: India and China continue their API manufacturing reign,” Regulatory Affairs Professionals Society (RAPS), November 8, 2024.
- Electronic Code of Federal Regulations (eCFR), US Food and Drug Administration, 21 C.F.R. Part 312, Subpart B, § 312.30 (“Protocol amendments”), accessed January 21, 2026.
- Joanne S. Eglovitch, “USP: India and China continue their API manufacturing reign,” Regulatory Affairs Professionals Society (RAPS), November 8, 2024.
- US Food and Drug Administration (FDA), “Safeguarding pharmaceutical supply chains in a global economy,” testimony of Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research (CDER) at the FDA before the House Committee on Energy and Commerce, Subcommittee on Health, October 30, 2019.
Dr. Laks Pernenkil
