The conduct of clinical trials is a demanding process. This requires not only the hiring of resources to perform various activities but also the material to support to actually execute different activities and processes. Some of these materials can be investigational products. But, a vast number of products could be non-investigational products required for the conduct of clinical trials. It becomes important to plan for procurement or import of these clinical trial ancillary supply products in advance.
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 importation 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
Having understood 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. PMDA, a Japanese regulatory authority is responsible for CTN. The sponsor needs to submit, at least, 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 important consideration for the importation of clinical trial ancillary supplies. As explained in the report referred to above, it can be instrumental in the whole process of import.
CTN is considered to be approved within 30 days and clinical trial activities, including importation, can be initiated.
Import Licence for Import of clinical trial ancillary
An import license may or may not be required for the importation of ancillary clinical supplies.
In Japan, clinical supplies are categorized into different categories. Depending on the product category, the requirements of import license can be ascertained for the clinical trial ancillary supplies.
Before initiating any process of importation, you need to first assess the category to which your ancillary product belongs, and applicable regulations to each product for 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 complete 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
- Obtains an Import license for the importation of the applicable goods.
- 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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