Shipping clinical trial materials, such as ancillaries, medical devices, or Investigational Medicinal Products (IMPs), to Japan requires a thorough understanding of the laws and local regulatory systems. Understanding the challenges for shipping clinical trial materials to Japan begins with recognizing how the country’s regulatory framework differs from most others. 

Japan’s clinical trial regulations differ from most countries in that they allow either an In-Country Caretaker (ICC) or Importer of Record (IOR) to manage imports. The ICC is a local Japanese entity that oversees the entire trial from Clinical Trial Notification (CTN) submission to completion. And the IOR takes ownership of goods at import. Both handle customs declarations, documentation, product registration requirements, and bear full responsibility for imported materials. 

In Japan, the complexity of the import process arises mainly due to the following reasons: 

• The need for precise documentation
• Strict customs clearance procedures
• Precise classification of products under the Harmonized System (HS) codes
• Coordination among multiple stakeholders, such as the ICC, IOR/EOR, and logistics providers
• Language barriers

These factors may contribute to further delays if mistakes occur in any of these steps. Moreover, not following the detailed customs procedure and strict regulations of Japan for shipping clinical trial materials may lead to shipping halts. Therefore, for easy customs clearance, adherence to quality standards and specific documents is essential. 

In this article, we will look into the various aspects of key requirements for shipping clinical trial materials to Japan, challenges that CRO’s and sponsors may face while shipping clinical trial materials, and the ways to overcome them.

Why shipping clinical trial materials to Japan is uniquely challenging

What makes Japan particularly challenging is the intersection of four critical factors: 

1. Language requirements

All documents need certified Japanese translations using exact regulatory terms. As even small translation errors can delay shipment, this step needs special attention to detail.

2. Strict PMDA and customs requirements

The rules are stringent and detailed in comparison to the FDA or EMA. The challenge begins with understanding and adhering to regulations (that may evolve). If not met precisely, it may often result in delays and penalties, followed by extended trial timelines. 

3. Limited shipping options

As an island nation, Japan has fewer freight routes and entry points, which limit its flexibility.

4. Complex delivery coordination

One needs to deliver materials to multiple clinical sites across Japan, each with different receiving capabilities and schedules. All this should be accomplished while also maintaining compliance with all regulations throughout.

For sponsors and CROs accustomed to FDA or EMA processes, Japan’s strict and close attention to detail approach may require them to be extra cautious and well-prepared. From obtaining the right permits to engaging the appropriate local partners, every requirement needs methodical assessment. So what exactly do you need to ship clinical trial materials to Japan? Let’s break down the essential requirements in the following section of this article: 

Requirement	Description	Issuing Authority/Responsible Party
Clinical Trial Notification (CTN) application	Includes protocol, investigator’s brochure, and other relevant documents.	The Pharmaceuticals and Medical Devices Agency (PMDA)
Clinical Trial Application (CTA) Documents	Includes the trial’s scientific justification, protocol, consent forms, Case Report Form sample, and Investigator’s Brochure.	The sponsor of a clinical trial is responsible for preparing and submitting the required documentation
Bilingual labelling on the package	All trial materials should be mandatorily labeled  in Japanese and/ English language	Importer of Records (IOR)
Commercial Invoices & Packaging	Detailed item description, barcodes, The label statement ‘For clinical trial use only’ is standard to indicate no commercial value	CRO/Sponsor
Air Way Bill (AWB) or Bill of Laden (B/L)	The contract of carriage and proof of shipment.	Airlines/Freight forwarders/IATA Cargo agents

Now that we have addressed the key requirements, we can move on to the top 5 challenges for shipping clinical trial materials to Japan, often faced by sponsors or CROs.

Challenges for shipping ancillaries, medical devices, and non-IMPs to Japan

1. Regulatory timelines

• Many sponsors underestimate the CTN review process and its timeline and begin planning only 2-3 months before their desired shipment date. By the time they realize documentation is missing or incorrect, trial start dates get compromised. 
• If the Investigator’s Brochure lacks a Japanese translation or the CTN doesn’t clearly state the import manifest, customs will hold the shipment until discrepancies are resolved. 
• Japan’s CTN process requires at least 30 days for PMDA review. But incomplete or incorrect documentation can extend timelines by weeks or even months.

2. HSN code classification

• Another challenge is product classification, which requires determining the correct Harmonized System (HS) tariff codes for various ancillaries and medical devices, which is complex. It is complex because rates and requirements vary considerably by product type. 
• Sponsors often treat HSN coding as an afterthought, assuming their global classification applies to Japan. 
• Attention to detail when not given in classification leads to missclassification, customs holds, and potential rejection of shipments. 
• For example, incorrect coding of diagnostic kits leads to weeks of clearance delays. Because customs need additional proof that they are trial-specific and not commercial products.

3. Product-specific requirements

• A common oversight occurs when sponsors focus solely on their drug product and overlook the ancillaries. Specialized infusion pumps, blood glucose monitors, or diagnostic imaging equipment may require separate PMDA import licenses or certificates proving they meet Japan’s GMP standards. 
• Without these, customs won’t release the items, even if the IMP has full CTN approval. For instance, temperature monitoring devices need Japan Medical Device Nomenclature (JMDN) codes and pre-clearance documentation.
• Medical devices with wireless or Bluetooth capabilities require some special regulatory markings, for example, Giteki certification (R-Mark and T-mark) under Japan’s Radio Law, usually obtained before customs clearance. 

4. Language barriers

• Japan requires certified Japanese translations of all critical documents using precise regulatory terminology. 
• Many sponsors rely on machine translations or general translation services unfamiliar with pharmaceutical terminology. This will result in documents that are technically accurate but regulatorily inappropriate. 
• Translating “Investigational Medicinal Product” incorrectly can create confusion about whether the shipment falls under CTN or commercial import rules. Labels not matching precisely with the CTN application may often lead to queries. And even invoices with minor translation errors can cause customs to halt clearance while they seek clarification. 
• A query that takes three days to resolve in English might take two weeks when it requires back-and-forth Japanese correspondence.

5. Choosing the right importer/exporter

• Selecting an inexperienced IOR/EOR is one of the most costly mistakes sponsors make. An entity unfamiliar with Japan’s pharmaceutical import regulations may mishandle customs valuations. And fail to properly declare trial-specific exemptions, or provide inadequate documentation during PMDA audits. 
• Temperature-controlled IMPs require specific cold chain documentation and real-time monitoring records, which an inexperienced IOR might not know are mandatory. 
• The authorised IOR without established relationships with Japanese couriers and temperature-controlled warehouses may struggle to maintain product integrity from port to site. 

All the above-mentioned points are critical and pose significant challenges to sponsors and CROs for delivering clinical trial materials to Japan. However, with careful planning, a thorough understanding of the needs, and partnering with the right experts, these challenges could be well-managed. 

The following section discusses the various mitigation strategies to overcome these challenges:

Mitigation strategies to overcome the challenges for shipping clinical trial materials to Japan

• Addressing all needs through pre-planning that addresses all requirements from documentation to delivery logistics. Keeping adequate buffer time in shipping schedules and establishing contingency plans for potential delays protects both product integrity and trial timelines.
• Sponsors and CROs can start by engaging a regulatory expert who doesn’t just understand PMDA requirements but also can verify product classifications and HS codes early. Addressing these fundamentals right from the beginning saves costly mistakes down the line.
• This could be managed by reviewing each product individually, as IMPs, Non-IMPs, ancillaries, medical devices, ancillary supplies, etc, all require different codes and documentation. These may need to be cross-referenced with PMDA’s import notification requirements. 
• Ensuring commercial invoices explicitly state the trial purpose and correctly mention CTN. This is to prevent misclassification that could lead to duty assessments, shipment rejection, or re-exportation.
• It is always advisable to partner with a Japanese-speaking logistics provider who can handle all documentation with precision, using proper regulatory terminology. Before submitting anything, pre-validating documentation formats with local customs contacts also ensures timely customs clearance. 
• Selecting an IOR/EOR with demonstrated pharmaceutical clinical trial import experience can guide you through the entire shipment process. That is from understanding compliance requirements to ensuring customs clearance, thereby resolving issues before they arise. Their expertise can help sponsors and CROs move forward with confidence and readiness with shipment procedures to countries like Japan. 

Conclusion

In conclusion, shipping clinical trial materials in Japan requires a very thorough understanding of its regulatory requirements mandated by the PMDA. And a strategic approach to every aspect of the supply chain. While the challenges are significant, they become smooth and manageable with the right preparation and partnerships. Close coordination with experienced IOR, EOR, and ICC partners also facilitates timely and smooth shipping procedures. It is therefore important for sponsors and CROs to engage with local expertise early, along with vendors/partners who can guide them throughout the process. 

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Are you planning to ship ancillaries, medical devices, or clinical trial materials to Japan? Or are you currently facing challenges with your shipments?

Our experts can help you understand Japan’s regulatory requirements, assist in preparing compliant documentation, secure necessary certifications, and coordinate with experienced local partners to ensure smooth customs clearance and timely delivery of your clinical trial materials. 

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