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 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.

Challenges for IMP importation

Here are some global challenges for IMPs import

• Require experts with knowledge in import regularly and distribution,
• Diversified import regulations for each country,
• Frequent change in the local regulations for import,
• Import and Distribution of shipment within time,
• Maintain the IMP temperature need and shipment tracking,
• Requires seamless integration between manufacturing, logistics, and technology,
• Return and destruction handling after completion.

For the importation of IMPs into Japan, it's very important to understand

• The regulatory approvals required for the import of these products
• Review & approval of IMPs
• Process of importation of ancillary supplies
• Responsibility of import for clinical trials
• Impact of various factors on the import process
• Timelines for the total importation process

Get details on the regulations, requirements, and process to import IMPs and IMP supportive products into Japan by downloading this report

Note: The details presented in the report are intended to help in creating awareness about the regulatory process and requirements for importing IMPs 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 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.