International Transportation of Investigational Medicinal Products (IMPs) / Key Requirements: Temperature Control, Customs Clearance, and Speed
- 3 days ago
- 3 min read
What Is International Transportation of Investigational Medicinal Products (IMPs)?
International transportation of investigational medicinal products (IMPs) refers to the entire logistics process of delivering unapproved drugs, comparators, and placebos used in clinical trials from manufacturing sites to clinical trial sites in Japan and overseas.
Unlike the transportation of approved pharmaceuticals, IMP logistics requires strict handling under product-specific temperature conditions. Any deviation from the temperature range specified in the clinical trial protocol may result in the risk of invalidating trial data. In addition, complete chain-of-custody records are essential throughout the transportation process.
Temperature Control
Many investigational medicinal products are biopharmaceuticals or antibody-based drugs, and temperature excursions can directly affect their efficacy and safety. It is therefore an absolute requirement that the temperature range defined in the clinical trial protocol is never exceeded at any point during transport.
Typical temperature ranges include:
+15°C to +25°C: oral dosage forms and some small-molecule compounds
+2°C to +8°C: antibody drugs and biologics
-20°C to -80°C: biopharmaceuticals and some cell therapy products
-150°C to -196°C: cell therapy products, regenerative medicine products, and CAR-T cells
Customs Clearance
Import procedures under Japan’s Pharmaceuticals and Medical Devices Act require customs clearance to be linked to the relevant clinical trial notification. If the shipment contains narcotic or psychotropic substances, an import permit from the Ministry of Health, Labour and Welfare is also required.
For exports, it is necessary to confirm compliance with Japan’s Export Trade Control Order and Foreign Exchange and Foreign Trade Act, as well as the import regulations of the destination country.
Because customs delays can directly affect clinical trial schedules, it is essential to have a customs clearance team specialized in biopharmaceutical shipments.
Speed
Patient dosing schedules, protocol start dates, and product expiry dates impose strict timelines on IMP transportation.
To meet these requirements, it is critical to eliminate delay risks through direct in-house handling from pickup to airport delivery, secure same-day or next-day flight departures, and process export customs clearance quickly through an in-house customs team.
Transportation Challenges in Multinational Multi-Site Trials (MIST)
In multinational multi-site trials, shipments must be delivered to dozens or even hundreds of trial sites, each with different customs requirements and delivery conditions.
This requires:
dynamic transportation scheduling aligned with patient randomization timing
immediate reporting to sponsors or CROs in the event of deviations, along with resupply arrangements
centralized management of transportation and temperature records that can withstand inspections by regulatory authorities in multiple countries
Why THERMAL™ Is Chosen for IMP Transportation
Our in-house customs clearance team eliminates communication loss and delay risks associated with outsourcing. With WHO GDP certification, we provide GDP-compliant transportation quality that meets the requirements of global pharmaceutical companies and CROs.
We support a wide range of temperature conditions, from +25°C to -196°C using liquid nitrogen cryoshippers, and issue GDP-based quality documentation for each shipment.
Frequently Asked Questions
Q. Is a special permit required to import investigational medicinal products?
A. Under Japan’s Pharmaceuticals and Medical Devices Act, it is necessary at the time of customs clearance to demonstrate that the products are intended for use in a clinical trial for which a clinical trial notification has been submitted. If the products contain narcotic or psychotropic ingredients, a separate import permit from the Ministry of Health, Labour and Welfare is required.
Q. What happens if a temperature excursion occurs?
A. We immediately report the incident to the sponsor or CRO. In accordance with GDP-compliant SOPs, we manage record preservation, root cause investigation, and reporting of corrective and preventive actions.
Q. Can you handle small initial shipments for Phase I trials?
A. Yes. Small-volume shipments are typically handled using dedicated compact passive containers. We can support shipments of any size, from small quantities to large palletized consignments.
Q. Can you also transport biological specimens such as blood or tissue samples?
A. Yes. We handle international transportation of biological specimens classified as UN3373. These shipments can also be arranged together with investigational medicinal product transportation.
Contact Us
Please feel free to contact us for any inquiries regarding the international transportation of investigational medicinal products.