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 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
Clinical ancillary supplies are a critical component of clinical trials that are required as part of the treatment specified in the protocol but are not considered as Investigational Medicinal Products (IMP).
Clinical ancillary supplies can be instruments, equipment, documents, medical supplies, e-diaries, etc. used by investigators for conducting clinical trials. These can be considered anything from the supplies required to administer an IV drug to EGC machines or even dietary supplements.
Ancillary supplies are often imported separately from the investigational medicinal products. Thus, various regulatory requirements, custom challenges, import documents for each of the categories of the ancillary supplies need to be considered before importation.
For importation of clinical trial supplies into Japan, it's very important to understand
The regulatory approvals required for the import of these products
Since the products are being imported for clinical trial purposes, the approvals required can be different than the approvals for marketed products.
Requirements applicable to different products
For products of various types, the requirements can be different. Thus, one may need an import license for some products, while for others such a license may not be required.
Process of importation of ancillary supplies
Once, the documents, approvals, and certificates required for import have been obtained, one must follow a series of steps to import, clear customs, and take delivery of the products.
Responsibility of import for clinical trials
Since the importation is for clinical trial purposes, the responsibility of importation must be defined and authorized in the correct manner.
Impact of various factors on the import process
Different aspects, e.g. port of entry or shipment may impact the import process in their own way. It's important to understand these nuances.
Timelines for the total importation process
It's crucial for a clinical trial project to estimate the time needed to get approvals and complete the process of important of clinical trial ancillary supplies.
Get Details on Regulatory Process, Requirements, and Aspects of Importation of Clinical Trial Ancillary Supplies.
With an increasing number of multi-site trials being conducted in different regions, we at Credevo, receive multiple queries asking for regulations and requirements of such importation. This may also be due to the fact that the information found on the internet could be incomplete, outdated, or at times unrelated. The practical scenario of regulatory compliance could have many more aspects to be considered.
Credevo has prepared a report by collecting the relevant information as per the current understanding and awareness of Credevo. Click on the blue button below to download the report.
What would you get by downloading this report?
- Details on the regulations, requirements, and process to import clinical ancillary supplies into Japan.
- Free assessment of your ancillary products by Credevo to check specific requirements that apply for import.
Note: The details presented in the report are intended to help in creating awareness about the regulatory process and requirements for importing clinical trial supplies into Japan. While the report can be considered as an informative resource, it is not being presented as legal guidance, a binding document, or any authoritative report. The information in this report was prepared on the basis of relevant information from the public domain as of the date, however, the PMDA regulations and requirements may change with time and it is advisable to refer to current regulations at any given time. It is recommended to confirm the specific details, requirements, and processes applicable to your specific products at a given time before initiating any process of importation.
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.
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 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.
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 belong to, and applicable regulations to each product for import.
The process of importation can be made easier based on the category of products, the status of your clinical trial application, and other factors. If you have downloaded the above referred Report ‘Japan: Clinical Ancillaries Import Requirements’, just fill up the information below to receive a free assessment of your ancillary supply products (up to 4 products) that need to be imported by Credevo experts to identify specific requirements that apply for importation.
With this assessment, you can also choose to receive a cost proposal for the importation of clinical ancillaries into Japan.
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 in Japan
The entire import process for clinical supplies may take approximately 5-14 business days and it depends upon the category n which your 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.