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 into Japan, it's very important to understand
- The regulatory approvals required for the import of these products
- Requirements applicable to different products
- 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