ReviewClinical pharmacology and therapeutics2022
Japan's Special Approval for Emergency System During the COVID-19 Pandemic.
Review in Clinical pharmacology and therapeutics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
8 citing papers in PubMed.
- An Evaluation of Foreign Clinical Data in the Approval Reviews of Antimicrobial Medicines in Japan: Considering Ethnic and Regional Differences in Data Extrapolations in Accordance With Regulatory Circumstances.Pharmacology research & perspectives · 2026Article
- Article
- In Vitro Diagnostics for SARS-CoV-2 Infection Authorized in the United States and Approved in Japan.Clinical and translational science · 2025Article
- Accelerating the approval of mpox vaccines based on lessons learnt from COVID-19 vaccines through the lens of regulatory science.BMJ global health · 2025Review
- Biotechnological Preparedness for Novel Pandemics: Diagnostic Performance of IVDS Against SARS-CoV-2.MicrobiologyOpen · 2025Review
- Article
- Points to consider for COVID-19 vaccine quality control and national lot release in Republic of Korea: focus on a viral vector platform.Osong public health and research perspectives · 2022Article
- A Prospective Study Regarding the Efficacy and Safety of the BNT162b2 Vaccine in Patients With Solid Malignancies Undergoing Systemic Chemotherapy.In vivo (Athens, Greece)Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
1 author.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.