MFDS Publishes Casebook on Approved Clinical Trial Plans for COVID-19 Therapeutics

[Image source=Yonhap News]

[Asia Economy Reporter Seo So-jeong] The Ministry of Food and Drug Safety (Minister Kim Gang-rip) will publish the "COVID-19 Therapeutics Clinical Trial Plan Approval Casebook," containing information on clinical trials approved domestically, on the 18th to assist pharmaceutical companies in developing COVID-19 treatments.

The Ministry of Food and Drug Safety prepared this casebook to help companies with limited clinical trial experience reduce trial and error by referring to actual approval cases and to expedite the development of domestic therapeutics.

The casebook includes ▲ the status of clinical trial approvals by mechanism of domestic COVID-19 therapeutics (antiviral agents, immunomodulators) ▲ information on the number of subjects, target population, major inclusion and exclusion criteria for individual clinical trials ▲ efficacy evaluation variables by clinical trial phase.

The Ministry of Food and Drug Safety stated, "We expect this casebook to provide practical assistance to companies," and added, "We will continue to support the development of domestic COVID-19 therapeutics by transparently disclosing key information on clinical trial plans."

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