Japan Aims To Approve Remdesivir In One Week

Japan Aims To Approve Remdesivir In One Week

May 2, 2020, 8:37 p.m.

Health minister Kato Katsunobu says Japan aims to approve remdesivir, the antiviral drug that may be used to treat coronavirus, in about one week after receiving an application from the pharmaceutical company.

The ministry would aim for swift approval through special, highly-simplified procedures only available for drugs in urgent need that have already been approved in other countries.

The move follows US authorization on Friday for emergency use of the drug for coronavirus patients.

Health ministry officials on Saturday circulated a proposal among Cabinet ministers to amend a government ordinance that would enable the drug's use in Japan.

Kato told reporters that he understands the drug company will submit an application soon, and that he had instructed his staff to get it approved in about a week.

He said, if approved under the special procedures, that would be the fastest in the world.

Kato said his ministry will work to secure a sufficient supply for Japan, capitalizing on the collaborative clinical trial it conducted with the United States and the relationship it has built with the drug company.

Asked about the mixed review the drug received about its effectiveness, he said the ministry has examined relevant documents, and will further discuss its safety and effectiveness.

Kato said he wants thorough discussions to reach a decision.

Source: NHK

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