Department of Regulatory Science, Faculty of Pharmacy, Meiji Pharmaceutical University, Tokyo, Japan.
Clin Pharmacol Ther. 2022 Mar;111(3):551-558. doi: 10.1002/cpt.2310. Epub 2021 Jun 18.
The development of drugs for coronavirus disease 2019 (COVID-19) is a global challenge. In Japan, remdesivir was approved in May 2020 for COVID-19 caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. In February 2021, a vaccine against COVID-19 was approved. These two approvals were made using the Special Approval for Emergency system in Japan. This Japanese system was started in 2010 and has been used to approve four drugs to date, including remdesivir and the Pfizer COVID-19 vaccine. This paper discusses future challenges for Japan's Special Approval for Emergency system and organizes what can be learned from experiences to date. As a result, I would like to point Out the following issues. (i) Special Approval for Emergency is a system for approving drugs approved overseas, not a system for approving drugs originally developed in Japan. A system to approve drugs that have not been approved in foreign countries needs to be considered. (ii) In the Special Approval for Emergency system, it is necessary to ensure that postmarketing activities are conducted in accordance with the Risk Management Plan and the conditions of approval, to disclose the results in a timely and speedy manner, and to judge the appropriateness of continued approval based on the results of postmarketing activities.
新型冠状病毒病（COVID-19）药物的研发是一项全球性的挑战。在日本，瑞德西韦于 2020 年 5 月获得批准，用于由严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）感染引起的 COVID-19。2021 年 2 月，COVID-19 疫苗获得批准。这两项批准都是使用日本的特别批准紧急制度做出的。该日本制度于 2010 年启动，迄今为止已批准了四种药物，包括瑞德西韦和辉瑞 COVID-19 疫苗。本文讨论了日本特别批准紧急制度的未来挑战，并对迄今为止的经验进行了总结，以供参考。结果，我想指出以下问题。（i）特别批准紧急制度是一种批准国外已批准药物的制度，而不是一种批准日本原研药物的制度。需要考虑一种批准国外未批准药物的制度。（ii）在特别批准紧急制度中，有必要确保按照风险管理计划和批准条件开展上市后活动，及时、迅速地公布结果，并根据上市后活动的结果判断继续批准的适当性。
