Planning a clinical trial in Japan

If you’re planning a clinical trial in Japan, one of the most important (and often overlooked) aspects is how to properly ship your ancillary supplies and non-IMPs. In particular, lab kits, diagnostic devices, and other materials may be required. Therefore, navigating import requirements is not always straightforward. With strict regulations and detailed customs procedures, a small mistake can lead to major delays.

In this article, we’ll walk you through what you need to know about shipping non-IMPs and ancillaries to Japan, including regulatory tips, documentation requirements, and practical advice to help your trial run smoothly.

Regulatory & compliance

Navigating Japan’s import regulations for clinical trials

Japan enforces stringent regulations when it comes to importing materials related to clinical research. Whether or not your shipment includes pharmaceutical products, its role in a clinical trial can place it under regulatory scrutiny. This includes non-IMPs and ancillary items like medical devices, collection kits, or diagnostic supplies.

To comply, you’ll need a solid understanding of required documents, such as study protocols, item specifications, and intended use. Missteps like incomplete paperwork or incorrect classification can lead to delays, fines, or customs rejection.

PMDA Guidelines: Key points before shipping

The Pharmaceuticals and Medical Devices Agency (PMDA) oversees all clinical trial activity in Japan. While non-IMPs and ancillaries don’t go through the same approval process as IMPs, they must still meet GCP and GDP standards.

Key expectations include:

Demonstrating the item’s role in the clinical trial
Ensuring that the import supports patient safety and ethical standards
Aligning documentation with study filings
Clearly defining the responsibilities of your Importer of Record (IOR)

Non-compliance can bring serious consequences, delays, regulatory queries, or even project disruption.

IOR/EOR compliance for ancillary supplies

Appointing a qualified Importer of Record (IOR) and Exporter of Record (EOR) is not just helpful, it’s essential. These entities ensure your materials meet all Japanese customs and regulatory requirements.

Their responsibilities include:

Filing accurate declarations with customs
Correctly classifying goods under HS codes
Coordinating with PMDA and customs officials as needed
Keeping clear documentation and audit trails

For clinical trials, it’s especially important to work with an IOR/EOR experienced in research logistics. Therefore, avoid relying on general trade providers to ensure nothing gets lost in translation.

Logistics & documentation

What documents do you need?

Smooth customs clearance depends on comprehensive and accurate documentation. Required documents typically include product details, clinical trial documents, and relevant technical information. However, the exact requirements will become clear once the type of product to be shipped is well understood.

Would you like to know which documents are required to import your clinical trial ancillaries, non-IMPs, or medical devices into Japan? Share the shipment details through the form below, and we’ll provide you with the relevant documentation and compliance guidance.

Errors or omissions in these documents are among the most common causes of customs delays.

Labeling & packaging essentials

Japan has specific rules for how trial materials should be labeled and packaged, even non-IMPs and ancillaries. Mistakes here can lead to customs holds or rejections.

Language: Labels should be in English and/or Japanese
Label Contents: Include product name, lot number, expiry date, and storage instructions
Usage Statement: “For Clinical Trial Use Only” is often required
Cold Chain: If temperature-sensitive, include proper loggers and markings
Packaging: Must be secure, tamper-proof, and clearly organized

Avoiding shipment Delays: What to watch out for

Some of the most common shipment problems include:

Documentation that doesn’t match shipment contents
Lack of clarity on the IOR/EOR role
Incorrect HS code classification
Missing import licenses for medical devices
PMDA filing misalignment

How to prevent them:

Work with an IOR/EOR that understands Japan’s clinical trial requirements
Double-check your paperwork before shipping
Communicate regularly with your logistics team and receiving sites
Prepare contingency plans for customs queries

Role of IOR/EOR in planning a clinical trial in Japan

As we detailed in our article, having the right IOR and EOR partner is critical for ensuring clinical trial shipments to Japan are smooth and compliant, especially if your organization doesn’t have a local office.

A knowledgeable IOR/EOR can:

Navigate regulatory hurdles
Submit correct import/export declarations
Keep your study on schedule

For more details, refer to our article on IOR/EOR roles in Japan’s clinical trial logistics.

Practical insights

Plan ahead to stay on track

Timing is everything when it comes to clinical trial logistics. To avoid delays:

Start planning 3–5 weeks in advance
Coordinate with local sites and regulatory teams
Account for holidays like Golden Week or New Year
Notify your IOR/EOR early so they can prepare

Real-world challenges & how to solve them

In past projects, we’ve seen:

Shipments held due to missing “Clinical Use Only” labels
Delays from using IORs who are unfamiliar with trial documentation
Confusion over HS code classification resulting in rejections

These issues were resolved by involving IOR/EOR partners early and conducting pre-shipment reviews.

Tips for smooth deliveries

Here’s how to ensure your shipments reach Japanese clinical sites without a hitch:

Confirm the IOR/EOR’s readiness early
Use logistics providers familiar with Japanese clinical trials
Prepare complete and accurate paperwork
Double-check labeling and packaging for local standards
Keep your sites informed and ready to receive shipments
Build extra time into your logistics schedule

Conclusion for planning a clinical trial in Japan

Successfully shipping ancillaries and non-IMPs for clinical trials in Japan requires careful planning, precise documentation, and close coordination with experienced IOR/EOR partners. By preparing early, aligning with PMDA guidelines, and ensuring compliance at every step, you can minimize delays and keep your study on track. Thoughtful logistics management is not just about moving goods; it’s about safeguarding your trial’s timeline and success.

Are you still facing challenges or have specific questions?

Are you struggling with complex documentation, navigating Japanese customs regulations, or perhaps facing unexpected delays in shipping ancillaries and medical devices for your clinical trials? If so, and if you want to ensure everything goes smoothly, fill out the form below. Our experienced team will connect with you to address your concerns and provide clear, step-by-step guidance for a compliant and efficient import process.