Comparator drug sourcing in the EU by the numbers
- 4 core challenges: limited availability, regulatory complexity, intense market competition, and logistical hurdles
- 5 mitigation strategies: strategic partnerships, advanced forecasting, regulatory preparedness, flexible sourcing, and coordinated logistics
- Multiple temperature ranges to manage across trials: +2-8°C, +15-25°C, and -20°C
- Dozens of regulatory interpretations across EU member states despite shared GDP principles
- High-demand comparators often controlled by a small number of suppliers, increasing allocation risk
Comparator drugs are the backbone of clinical trials, determining not only the scientific validity of a study but also its operational continuity and importance. In the EU, where healthcare systems and regulatory expectations vary widely across all the member states, sourcing comparators requires more than just access. It requires foresight, coordination, follow up, and a solid understanding of market behavior.
Working closely with the industries like sponsors, CROs, manufacturers, and licensed wholesalers across Europe has shown me how critical timely and compliant access is. Delays in securing comparator products can slow down patient enrollment, disrupt study timelines, and increase overall project complexity and costing.
In this article I share practical insights from day-to-day experience in navigating these realities.
Key challenges
Limited availability
As I have seen, many comparator drugs, especially rare molecules, branded generics, and orphan drugs are not readily available in large quantities. Supply is often fragmented across EU countries, and manufacturers may prioritize their existing partners or domestic demand rather than providing support for clinical trials. Also, seasonal shortages or production delays further complicate total planning of the trial.
Regulatory complexity
In my experience I have seen, while the EU operates under shared principles, each country interprets and enforces regulations slightly differently and changing periodically. Requirements tied to EU GDP compliance, and local authorizations can differ from one jurisdiction to another. I believe navigating these layers demands close attention to documentation, wholesaler licenses, and transport obligations.
Intense market competition
I have seen many times that every sponsor, CRO, and other procurement teams often chase the same high-demand comparators continuously. In some therapeutic areas, a handful of suppliers dominate the market, and exclusivity agreements limit access for smaller or newer partners in this field. Ultimately, this competition frequently leads to unpredictable supply timelines and last-minute allocation challenges.
Logistical hurdles
In a particular project I have seen, even after securing stock, the work is far from complete. Cold-chain handling, temperature-controlled storage (+2/-8, +15-25 even -20), and multi-site deliveries across various EU regions require a highly coordinated logistics plan. I think, any misstep from delays at customs to insufficient packaging can jeopardize the integrity of the product.
Real-world strategies
Strategic vendor selection and partnerships
From my experience overview, long-term relationships with reliable wholesalers, manufacturers, and pre-qualified suppliers are essential. I mostly believe that consistency builds trust, and trusted partners are more likely to allocate scarce products during high-demand periods. I must say, if we can engage our partners early in the process, it opens doors to better lead times and clearer communication.
Advanced forecasting and planning
In the field of clinical trials, forecasting is one of the strongest tools in comparator procurement. I have seen in many cases, when a sponsor shares anticipated timelines and quantity estimates early, it becomes easier for any supplier to map out sourcing routes, secure reservations, and maintain buffer stocks where necessary. Even rough projections help reduce uncertainty.
Strengthened regulatory preparedness
It is important to understand that staying ahead of regulatory guidelines and changing expectations prevents repeated back-and-forth at critical moments. We should maintain GDP-aligned documentation, batch records, transport validation, and approvals so that it ensures smoother audits and avoids unnecessary delays. In my case, working closely with partners who understand local regulatory nuances adds another layer of protection.
Flexible sourcing and backup options
In my career, I have seen rigid sourcing plans rarely survive unchanged. I think exploring parallel routes; whether through authorized imports, alternative strengths, or equivalent comparator options can keep trials on track when the primary product is limited or shortage. It is always important to have backup suppliers which can help to reduce dependency and give room to maneuver during shortages period.
Efficient distribution and logistics management
In my clinical trials career, I have learned many times that comparator supply is only successful when the product reaches every trial site safely and on time. I believe coordinated multi-site distribution, validated cold-chain monitoring, temperature-controlled transport, and contingency plans create the backbone of reliable delivery. Therefore, real-time communication with logistics teams ensures transparency at every step.
Practical advice
I believe successful comparator procurement is always a collaborative effort. When we open communication between sponsors, CROs, and wholesalers, we ensure that challenges are identified early and mitigated before they affect trial operations. It is important for us to incorporate risk-based planning, alternative sourcing pathways, and flexible logistics preparation which could significantly improves the reliability of our supply chain.
Securing comparator drugs in the EU is a complex process shaped by availability constraints, regulatory expectations, and competitive market behavior. But if we have the right planning, strong partnerships, and an adaptive sourcing strategy, we can possibly navigate these challenges effectively.
For global sponsors, CROs, and supply chain professionals, proactive preparation and regulatory diligence remain the strongest tools for us to avoid disruption and maintain trial momentum.
Syed Fazle Rob, RPh, head of global business development, AF Pharma Distribuce léčiv s.r.o.
