This notice is intended to facilitate clinical trials for COVID-19 related drugs and medical devices in Japan. It is reported that some clinical trials of medicines intended potentially to treat COVID-19 have already started, or will start soon, and it is possible that they may benefit from this new policy.
Although no regulatory change has been reported, according to a news report in an industry publication, some Japanese pharmaceutical companies are anxious about potential delays in clinical trials not related to COVID-19 that may be caused by the spread of COVID-19. In a survey of pharmaceutical companies, a few reported that their employees’ visits to hospitals or other institutions implementing clinical trials have been restricted.
Some companies are also reported to be implementing internal regulations on employees’ visits to hospitals in order to prevent the further spread of COVID-19. Restrictions on visits to hospitals and other institutions may inhibit the collection of data required for clinical trials, and may cause delays in clinical trials. According to the same news report, a considerable number of pharmaceutical companies appear to have not yet seen a critical impact on their clinical trials, but it is unclear whether there will be any potential impact in the future given their typically lengthy duration.
Authored by Mitsuhiro Yoshimura, Kyle Reykalin, and Frederick Ch’en