Kyle Reykalin

Kyle Reykalin

Hogan Lovells

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The impact of COVID-19 on clinical trials and countermeasure development in Japan

On 19 March 2020, the Ministry of Health, Labour and Welfare of Japan (MHLW) issued a notice announcing a waiver of the statutorily-required waiting period after submitting a request for clinical trial to the MHLW in respect...more

4/3/2020  /  Clinical Trials , Coronavirus/COVID-19 , Japan , Life Sciences , Pharmaceutical Industry , Research and Development , Waiting Periods , Waivers

Japan considers utilization of “compassionate use” exception to fast-track COVID-19 treatments

While several drugs are being studied in Japan to treat COVID-19, none have yet been approved. However, reports indicate remdesivir, a drug developed by as a treatment for Ebola virus disease, has been administered as a...more

3/30/2020  /  Coronavirus/COVID-19 , Drug Approvals , Emergency Management Plans , Life Sciences , Patient Access , Pharmaceutical Distribution , Pharmaceutical Industry , Relief Measures

Japan waives clinical trial waiting period for COVID-19 treatments

On 19 March 2020, the Ministry of Health, Labour and Welfare of Japan (MHLW) issued a notice announcing a waiver of the statutorily-required waiting period after submitting a request for clinical trial to the MHLW in respect...more

3/30/2020  /  Biotechnology , Clinical Trials , Coronavirus/COVID-19 , Emergency Management Plans , Japan , Life Sciences , Pharmaceutical Industry , Relief Measures , Research and Development
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