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Sourcing Commercial Drugs for
Clinical Trials: US vs. EU
Understanding the Differences
Sourcing commercial drugs for clinical trials is a dynamic process. There are many factors to consider: single source or regional sourcing, strategy, price, supplyavailability, lead times, and documentation are just a few. In the past, there were TS fewerclinicaltrialsthatrequiredcommercialdrugsourcing,sodemandwasnot as high. Today, the demand for commercial drugs in clinical trials has greatly R increasedand,asaresult,inventoryistighter,ordersaremonitoredmoreclosely by manufacturers, and lead times have increased. This report highlights the keydifferences in sourcing from the US and EU.
US SOURCING
EU SOURCING
Supply Availability
• Products can be more readily purchased directly YO EPO manufacturertoADR(AuthorizedDistributerof frommanufacturers,thoughsuppliesvaryby
Record) to pharmacies, hospitals, and secondary country/manufacturer. Smaller quantities may be available on a country level, but often not enough • Brand manufacturers will typically only sell to supply a larger trial at one time.
• Manufacturers may direct CT purchases to one M R volumeofbusinessinordertoestablishan specificcountry.
• Products will have EU and/or country-specific • Large volumes typically available in 2 – 3 weeks.
• Supply is tightly managed by IMAs (Inventory • Lead times range from 2 – 3 weeks to Management Agreements) with manufacturers.
6 – 7 months depending on product, quantity, Prevents speculative buying ahead of potential • Each package size and strength have individual • FDA requires Pedigree Documentation for all Sample Lead Times for Large Volume Purchases
For more information about
sourcing in the US and EU,
call +1-610-233-3300 or
email sales@myoderm.com
• Governments typically set pricing.
• Pricing is transparent, as WAC is industry accepted.
• Pricing typically lower than US market, but • Price increases typically are 1 or 2 times per year, wide variances on a country by country basis.
and average 2 – 10% per increase. Generics are • Manufacturers may price CT supplies higher an exception, with pricing sometimes 80 – 90% distribution, and management of commercial pharmaceutical products and supplies forclinical trials. Our clients span the globe Sample Price Comparisons
and include the majority of the world’s top10 pharmaceutical companies. With our deep expertise, customized solutions, andpersonalized service, Myoderm provides the optimal drug supply solution for globalclinical studies.
Manufacturer Cooperation
• Drug supply not usually an issue, as most • Manufacturers typically do not refuse to supply manufacturers do not require information.
drug, but some require EUDRACT or additional • Branded manufacturers typically do not provide • Most manufacturers supply COA, BSE/TSE, • Only 20 – 30% of branded manufacturers supply equivalency and other documentation, such as COAs, but generics are more supporting.
All product names mentioned in this publication are tradenames, trademarks, or registered trademarks of their respective owners.

Source: http://www.samedanltd.com/uploads/pdf/white_paper/1353068032_Myoderm_%20White_Paper_US_vs_EU_A4.pdf