Recommended Approach ยป
The import of clinical supplies into the US has grown more
Recommended Approach
to Navigating US Import Laws
Figure 8.
complicated over the years, but information and experts are
available to help navigate the process.
We encourage you to identify a customs broker early in the
process, as setting up the initial paperwork (bond application
and power of attorney) can take a few weeks to complete.
Experienced quality and regulatory professionals pick-up where
the customs broker leaves off, ensuring that applicable FDA and
importation requirements are met and product quality is
maintained throughout the entire supply chain.
Lastly, consider your global development plan. While many
clinical trials are planned for US sites only, expansion to the
EU or other areas may be necessary due to subject enrollment,
Global Pharmaceutical Contract
Manufacturing and Contract Research Organization
Figure 9.
costs, or other drivers.
Unfortunately, having a US IND in effect is rarely sufficient for
importation of clinical supplies into other countries. Each region/
country has its own regulations and challenges, and the impact
on costs and timelines can be significant without proper planning
and an in-depth understanding of the requirements.
For a global approac h to drug development, it is necessary to
engage a truly global clinical development team.
clinipace.com
7