Getting the study drug at the right time is challenging for any clinical trial, and this is more prominent with multi-regional clinical trials. To import and have the IMPs and ancillaries at the clinical trial sites in time, the sponsors need to have the right people, processes, facilities, and technology in place.
Note: This article was last updated in September 2022
Generally, the sites require three types of supplies during clinical trials
- IMPs and their supportive products (i.e. Investigational and Non-Investigational medical products).
- Laboratory supplies such as sample collection tubes, laboratory kits.
- Ancillary supplies such as medical devices, equipment, documents, etc.
In this article, we will be focusing on IMPs and their supportive products.
Challenges to import IMPs into Japan
Here are some global challenges for the import of IMPs
- Require experts with knowledge in import regulatory, depot and distribution,
- Diversified import regulations for each country,
- Frequent changes in the local import regulations,
- Import, depot, and distribution of shipment within time,
- Maintain the IMP temperature and tracking of shipment
- Requires seamless integration between manufacturing, logistics, and technology,
- Return and destruction handling after completion.
Regulatory to import IMPs into Japan
- The Pharmaceuticals and Medical Devices Agency (PMDA) is the regulatory authority that regulates the clinical trial approval and the import of IMP.
- You will require an In-country caretaker (ICC) to import IMPs into Japan.
- The ICC represents the importer to the Japanese government and undertakes the following responsibilities
- Recover the shipment upon arrival,
- Bring it to the customs warehouse,
- Present the appropriate documents and paperwork to customs, and
- Answer any questions that the Japanese government may have.
- The documents required for import of IMP depend on the type of study and the IMP.
- The sponsor needs to list the IMP and the supportive products in the “Clinical Trial Notification (CTN)”
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Clinical Trial Notification
To import the IMP’s and their supportive products, the sponsor/applicant need to list the products in the clinical trial application, as this facilitates the importation process and customs clearance process.
The documents required for the CTA include
- Statement regarding the reason why the sponsoring of the proposed clinical trial is scientifically justified,
- A protocol of the proposed clinical trial,
- An explanation document used for informed consent and consent form,
- A Sample of Case Report Form, and
- Current investigator’s brochure.
Note: All the documents need to be in Japanese.
The sponsor shall submit a notification and protocol to the PMDA before initiating any clinical trial.
PMDA assesses whether a proposed study complies with the requirements for regulatory submission, taking the science proposed data collection, analysis techniques, patient safety, and ethics into consideration and implements the Clinical trial consultation system, where the PMDA gives guidance and advice concerning study protocols.
The CTN can be in English however on request sponsor may need to submit a copy in the Japanese language. The PMDA evaluates the clinical trial application along with the list of IMP products mentioned in the application.
The PMDA approves the import of IMP products along with the CTN. After approval, the sponsor can initiate the clinical trials along with IMP import in coordination with the ICC or the CRO.
To import the IMP and supporting products, the sponsor requires various documents that may include CTA, data on comparators, commercial invoices, etc.
Usually, the import license is not necessary but may vary with the individual scenario.
Who handles your import?
The expert partner manages the clinical trial right from making a clinical trial application to providing the study report to the sponsor, along with the import of IMP and ancillary supplies for the clinical trials. These are usually known as In-country caretakers. The CRO who handles all these clinical trials operations also handles the importation and is referred to as the ICC.
The ICC should be an expert in import regulations to avoid glitches and delays during importation. For this, they may partner with the experts for logistics and the local regulatory service providers that help in the handling of imports. Choosing better logistic partners helps in efficient, safe, and economical importation.
Importer Of Record (IOR)
For import of IMP, the IOR – Importer Of Record, is not usually necessary as the duties of the IOR is limited. The IOR can only help in the ancillaries import where the import of these does not require an import license and need to list in the CTN. CROs usually handle all these tasks.
The role of IOR is required while importing the clinical ancillary supplies and non-medical products, which usually do not require listing in the CTN and can import by fulfilling certain requirements.
Labeling and packing
To import medicines from overseas is subject to control by the Pharmaceutical Affairs Law and the Customs Law to prevent health hazards caused by defective products.
The sponsor shall mention the details such as “For trial use only”, the name and address of the sponsor of the Clinical Trial, Chemical name or identification code, etc on the label during the importation of products.
The packing is also an important consideration for importation.
Some of the points that need to be considered.
- How the barcode and labeling will be used for easy tracking
- Check whether the packaging fits into the controlled temperature system
- Check whether the packing is as per the Japanese norms
Listing the IMPs in the clinical trial application helps facilitate customs clearance. Presenting the CTN is usually sufficient for custom clearance. For custom clearance other than import license (if applicable) or/and the CTN, the importer may require to provide documents such as commercial invoice, freight costs, etc.
Depot & Distribution
Having a depot for moving the shipment from customs to the depot is very important. Temperature management of IMPs is critical and challenging for logistic providers.
Choosing an experienced logistic partner having the necessary vehicles that maintain temperature to handle these IMPs is crucial. The logistics with experience will also have a well-structured tracking system that helps in proper monitoring of supplies till they reach the destination.
Once the goods reach the depot, they are distributed to the sites to conduct clinical trials.
Tips for a successful importation
- Need to plan for importation in advance with review of the complete list of IMPs and the support necessary for import.
- Sorting all the required IMPs and supportive products to list in the CTN before making a clinical trial application.
- Partner with an efficient ICC who handles all the process of importation with a previous successful track record
- Understand the requirements, segregate, and compile before making the importation.
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