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Health Ministry to skip clinical trials in approving Avigan for COVID-19 treatment

  • May 13, 2020
  • , Asahi, Nikkei
  • JMH Summary

Asahi and Nikkei reported on Wednesday that the Health Ministry decided on Tuesday that when applying for approval of new drugs to treat COVID-19, pharmaceutical companies will be exempted from submitting the results of clinical trials. The waiver is intended to swiftly identify and approve new treatments for the virus such as the flu drug Avigan. While exempting pharmaceutical makers from the prior submission requirement, the ministry will still ask them to present data verifying the safety and the effectiveness of their proposed drugs learned through publicly financed, high-level research programs. Applicants will also be required to submit the results of their clinical trials after approval is issued. The dailies said some experts are concerned that drug safety screening processes may be compromised under the public health emergency.

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