These costs and schedule adjustments will require advanced planning and communication with your entire development team. For example,
Clinical Operations must be aware of the schedule to properly plan for site activation and study subject screenings. For full drug development
programs, Clinipace Global RSD works with our Clinical Operations teams and Project Managers to ensure that everyone is working from the same
schedule and fully understands the costs, timing, and API requirements.
Consequences of Import Refusal »
Failure to understand the new requirements may (again – this is not yet being uniformly applied) result in an import refusal if you try to bring
API/drug product intended for clinical use into the US in advance of the IND being in effect. An import refusal is time consuming to overcome.
In the example scenario, the entire refused shipment must be exported back to China, which requires a whole new set of permits and shipping
documentation. It may be tempting to send the material back to China as quickly as possible and then try to re-import just enough to make a small
IND-enabling data batch. However, China does not allow material to be exported immediately after import. Any portion of the shipment remains
ineligible for re-export for 10 days.
All told, you are looking at adding a month to your schedule (Figure 6) if you receive an import refusal. Attempts to circumvent this requirement
by mislabeling the materials, failing to completely state the true use of the material in the importation paperwork, “shopping” ports of entry,
or other tactics are strongly discouraged. In the Regulatory Procedures Manual, the FDA describes the priority enforcement strategies for
problem importers.8
Figure 6.
Example Re-Importation Timelines After Import Refusal
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