The conduct of clinical trials is a critical process. Along with resource hiring, it also requires materials for different activities. Some of these materials can be investigational products. But, a vast number of products could be non-investigational products necessary for the conduct of clinical trials. It becomes critical to plan for procurement or import of these clinical trial ancillary supply products in advance.
Note: This article was last updated in September 2022.
In Japan, the process and the regulations for the importation of clinical supplies are slightly different. However, products need to be completely in compliance with Japanese standards.
For the import of clinical trial supplies in Japan, it’s important to understand the
- Regulations and processes related to the import of clinical ancillary supplies in Japan
- Required documents and approvals for seeking approvals for such import
- Entities or personnel who can be authorized for import of these products
- The role that different factors such as the origin of port and port of import play, and
- Cost and timelines for the entire process of import
After understanding the requirements, regulations, and process for the import, it’s time to check different requirements applicable to your specific clinical trial and ancillary supplies.
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Clinical Trial Notification (CTN)
In Japan, Clinical Trial Notification (CTN) is the most crucial regulatory approval required to initiate any clinical trial-related process. Pharmaceuticals and Medical Devices Agency (PMDA), a Japanese regulatory authority, is responsible for CTN. The sponsor shall submit the following documents as a part of a CTN procedure.
- Scientific justification for conducting a clinical trial
- Clinical Trial Protocol
- An informed consent form
- A sample of the case report form
- Investigator’s brochure, etc.
CTN is also an crucial consideration for import of clinical trial ancillary supplies. As explained in the report referred to above, it can be instrumental in the whole import process.
One can consider the clinical trial approved after 30 days and initiate clinical trial-related activities, including import.
Who will be the importer for clinical trial ancillaries?
In Japan, the scenario is somewhat different from other countries, and it will be important to know about
- In-Country Caretaker (ICC)
- Importer of Record (IOR)
In-Country Caretaker (ICC)
An In-Country Caretaker (ICC) can be assigned to handle the clinical trial, right from CTN application to the completion of the study, including the importation process. An In-Country Caretaker can be a local or Japanese entity.
Importer of Record (IOR)
An Importer of the Record (IOR) is the person or entity who takes ownership of the imported goods at the time of import.
What duties does the ICC/IOR perform on behalf of the Importer?
An ICC/IOR performs the following duties on behalf of the importer as follows
- Checks if the product needs special registrations.
- Acts as an importer for customs and tax declaration purposes.
- Ensures proper documentation and valuation of all the goods for import.
- Takes complete authority over the imported products, etc.
Custom Clearance for the Import of clinical trial ancillary into Japan
The entire import process for clinical supplies may take approximately 5-14 business days and it depends upon the category to which your ancillary supplies belong.
After the customs clearance, the importer ships the products directly to the site destination or arranges a depot for storage if required.
Depot & packaging for importation
In Japan, the packaging is required to be in compliance with the Japanese standards when it reaches the site. It should be in an acceptable manner. Also, it is preferable to have a local depot for storage in proper condition before it reaches the site in Japan. An ICC/IOR can manage this task well before on behalf of a foreign sponsor.
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