How to Expedite Customs Clearance for Clinical Trial Imports

‘Strictness’ usually comes from layered approvals required to ship clinical trial commodities into countries. This includes the layer of health regulators, plus strict customs, and sometimes a third authority. Some countries with complex importing and exporting customs include:

Several complications can make import and export shipping lanes considerably more complex. Exporting biological samples out of countries such as China, India, and Brazil, as well as parts of Latin America and Africa, requires compliance with national rules governing genetic material. Temperature-controlled shipments bring their own challenges, particularly when they travel into hot climates with long customs dwell times, where any delay can threaten product stability.

Another regulatory layer is added for controlled substances, since they require import and export certificates on both sides of the border. Lanes with destinations reached through transit hubs introduce further uncertainty, because each additional border crossing adds risk.

One framing point is worth making: by the time of the SIV, customs clearance should already be complete. Of all the deadlines in a clinical trial, the Site Initiation Visit (SIV) date is the most critical, as it marks the point at which the site is approved to begin the study.

Before a trial can begin, all pre-study compliance requirements must be fulfilled. In addition, every commodity required for the study must be on site, including both the investigational product (IP) and ancillary non-IP equipment, and each must be available in the volumes specified by the study protocol.

“IP on-site and ready” assumes clearance went smoothly, so customs readiness should be treated as a pre-SIV workstream. The SIV can’t happen without smooth customs clearance. The SIV Checklist consists of the following:

• Import permits or licenses are approved and valid for the quantities, product presentations, and duration of the trial, including planned resupplies.
• The IOR is formally appointed and named consistently across permits and shipping documents.
• Permit expiry dates are tracked against the resupply schedule, so a lapsed permit doesn’t stall a future shipment.

• The commercial or pro forma invoice shows the correct HS classification, an accurate customs value, and the “no commercial value” declaration where applicable. Even free-of-charge IMP needs a declared value.
• The packing list, air waybill, and certificate of analysis are complete, and batch numbers, quantities, and consignee details match the import permit exactly.
• GMP certification and QP release documentation are available where the destination requires them.
• Any duty or VAT exemption or relief is claimed correctly, with supporting documents such as the ethics approval or regulator authorization.

• Temperature logger data from transit have been reviewed, and any excursions were assessed before the IP was released for use.
• Chain of custody is documented from depot to site.

• Customs entries, permits, shipping records, and temperature data are filed in the Trial Master File or Investigator Site File and should be readily available, as inspectors and sponsor auditors may ask how IP entered the country.
• Records are retained for the period required by both GCP and local customs law, which may differ by country.

• Plans for returns, destruction, or reconciliation of unused IP are agreed upon, including any export permits needed to send products back.
• Arrangements for exporting biological samples are in place: permits, IATA-trained staff for packaging, and courier bookings.

The level of complexity and duration of clearance depend on both the commodity and the destination. The commodity sets the baseline difficulty, and the region decides how many extra layers apply. These commodities include:

There is an entire other category of commodities that are difficult to ship: medical devices classified as dual-use goods. These commodities can fall under export control lists and can trigger telecom-type approvals. Some lab equipment, reagents, and software-enabled devices are classified as dual-use goods.

Check out our solutions for other commodities: Paper Materials | Pharmaceuticals | Tech Devices | Patient Recruitment Materials | Lab Kits | Medical Devices | Biological Samples

TecEx Medical has the expertise to provide risk-free import and customs compliance solutions to Contract Manufacturing Organizations, Contract Research Organizations, sponsors, and Vendors in the clinical trial space, ensuring customs clearance.