There is nothing more frustrating than experiencing product loss and subsequent patient impact because a critical shipment was delayed in customs – often for something as simple has having incorrect paperwork, or lack of familiarity on the part of the local customs officials.
Each country is subject to a unique regulatory environment. For a trial sponsor that is expanding into a new geographic region, the time required to understand the guidelines is likely better invested on raising funds and/or developing new therapies.
In our experience of supporting shipments to 120+ countries, we have come to appreciate the value of a global database containing the latest guidelines. Equally important is the benefit of in-country expertise and colleagues that develop relationships with local brokers and customs officials.
Here are some of our lessons learned:
- Cultivate relationships with customs brokers who are experienced with clinical supply shipments.
- Leverage these relationships to ensure you remain current on the latest regulatory guidelines.
- Document regulatory requirements in a database that is easily accessed as reference for future shipments.
- When a regulatory requirement changes, immediately brief all parties involved in the operational and support aspect of moving goods so that, where appropriate, procedures can be updated.
- Educate the local customs officials and brokers if you are expanding to an emerging region that is unfamiliar with the materials. Show them the shipper, and explain the critical nature of the materials that are arriving. Review the regulations with them. After all, who wants to impact a patient waiting for a life-saving therapy?
- Take the necessary time up front to make sure every detail has been addressed and, most importantly, that the value is clearly and consistently defined. In the event a value is incorrectly declared by an importer, all future shipments will be subject to inspection.
- Where a given country allows it, work with the broker to ‘pre-clear’ a shipment in advance of its arrival.
Perhaps our most valuable tip is communicate, communicate, communicate.
When working with clinical trial sponsors we do everything within our control to help streamline the customs clearance process. Where allowable, we can act as Importer of Record to further reduce the number of handoffs in the supply chain. Ideally we can serve as a single point of contact for the end-to-end supply chain, providing full transparency to shipment status at every step in the process. This approach allows trial sponsors to apply their resources to higher value, core strength priorities.