The approval process for a drug in Japan usually takes about a year, but for remdesivir, the approval process is expected to be unprecedentedly fast. At a post-cabinet press conference on April 28, the Health, Labor and Welfare Minister said of remdesivir, “In the event that an urgent approval is granted for its use overseas, we would like to proceed with the approval review using the special approval system as soon as possible.
Special approval is available for products sold in countries that are judged to be necessary to prevent the spread of diseases that may have a serious impact on the health of the people and have the same level of approval system as Japan. There is no need to conduct clinical trials in Japan as is the case with ordinary drugs. It requires fewer documents to be submitted in the review of pharmaceutical approvals and simplifies the procedure.
The medicine of a great nation, rather than the medicine of its own.