New corona-related drug is the highest priority, and examination and approval procedures are simplified. Ministry of Health, Labor and Welfare May 12, 18:39
In an effort to accelerate the development of new coronavirus treatments, the MHLW has decided to simplify the process of reviewing and approving new coronavirus-related drugs with the highest priority.
Regarding the therapeutic drug for the new coronavirus, "lemdecivir" was approved for the first time in Japan this month, but research on several other drugs is also underway in Japan and overseas.
The Ministry of Health, Labor and Welfare has decided to take a special priority on the new coronavirus-related drugs and medical devices in order to accelerate development and commercialization, and to take special measures to greatly simplify the approval process. , Issued a notification.
Even if we do not have the data for clinical trials necessary for normal approval, if official research confirms a certain level of efficacy and safety, it may be possible to approve it if the conditions are met. .
It is necessary to explain to the patient and obtain their consent before using a therapeutic drug approved for special treatment.
Pharmaceutical companies may be required to submit clinical trial data after approval, but if approval and safety cannot be confirmed, approval may be withdrawn.
Among the drugs that are expected to have a therapeutic effect on the new coronavirus, "Abigan" developed by a domestic pharmaceutical company is undergoing clinical trials by the company as well as public research at the same time. Once the efficacy is confirmed, approval is possible even when the clinical trial results are not complete.