Companies looking to replicate a drug’s EU market success in the US will face significant hurdles unless they are fully aware of the ever-changing national and state requirements and regulations, says Two Labs’ Howard Miller.
As the world’s largest single pharmaceutical market, the US should – at least at first glance – provide a simplified pathway for companies looking for a stateside translation of their successes in Europe’s patchwork quilt of countries. Unfortunately, that’s anything but the case.
In reality, the US provides plenty of hurdles for the unwary with ample consequences. These are counterparts to the different regulations and requirements found across Europe.
Howard Miller is CEO of the Ohio-based strategic consulting and commercialisation firm, Two Labs, a division of Envision Pharma Group.
“When working with EU based pharma manufacturers that are bringing drugs into the US market, there are specific challenges that need addressed,” he notes. “For example, in order to distribute products in the US market you have to obtain a license or waiver from each individual state and all of the states have unique requirements. That process can take more than a year to complete. Further complicating things is that a manufacturer must have identified a third-party logistics partner even before initiating the licensing process. While there may be commonalities in the patients’ need for a drug, the route it takes to get to the patient is different from the EU to the US.”
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