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 of treatments related to COVID-19. Typically, any person or legal entity that submits a request for clinical trial to the MHLW must wait 30 days from the date of request before starting a clinical trial, in order for the MHLW to investigate health and sanitary issues that may occur in connection with the proposed trial (Article 80-2, Paragraph 3 of the Pharmaceuticals and Medical Devices Act). However, the new circular notice enables pharmaceutical companies, medical device companies, or doctors to start clinical trials for drugs or medical devices that are considered necessary to prevent and/or treat COVID-19 without the 30 day waiting period. This 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 reported to be 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 companies 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 visit to hospitals and other institutions may inhibit the collection of data required for clinical trials, and may cause delay 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 typical long duration.
On 1 April 2020, the Pharmaceuticals and Medical Devices Agency (PMDA) issued a Q&A in respect of the implementation of clinical trials in the current COVID-19 conditions. The Q&A provides guidance on, among other things, how to address difficulties in respect of: participants visiting a medical institution to receive treatment; holding a physical IRB (Institutional Review Board) meeting; implementing on-site monitoring by a sponsor; and addressing deviations from the study protocol.
Authored by Frederick Ch'en, Mitsuhiro Yoshimura, and Kyle Reykalin