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Comparative Study
. 2024 Sep 16;19(9):e0309992.
doi: 10.1371/journal.pone.0309992. eCollection 2024.

Comparison of regulatory approval system for medicines in emergency among Japan, the United States, the United Kingdom, Europe, and China

Kazuki Edo  1 , Masahide Kawano  2   3 , Hideki Maeda  1   2
Affiliations
Comparative Study

Comparison of regulatory approval system for medicines in emergency among Japan, the United States, the United Kingdom, Europe, and China

Kazuki Edo et al. PLoS One. .

Abstract

The approval of pharmaceuticals in response to the COVID-19 pandemic is a global concern, and during emergencies, emergency approval or authorization systems that enable the rapid use of unapproved drugs to maintain national health are essential. However, there is limited research comparing these systems across countries and their effects. This cross-sectional study examined such systems in Japan (JP), Europe (EU), the United Kingdom (UK), and China (CN) for pharmaceuticals (n = 23) authorized under Emergency Use Authorization (EUA) in the United States (US) between December 2019 to July 2023. As of the end of July 2023, JP had granted approval or permission for 14 drugs (60.9%), EU for 14 (60.9%), UK for 12 (52.2%), and CN for three (13.0%). An examination of the developmental status of the 23 drugs revealed that JP had 6 drugs (26.1%), the EU had 3 drugs (8.7%), the UK had 5 drugs (21.7%), and CN had 16 drugs (69.6%) yet to be developed. The US had significantly more granted permissions and developed drugs, while CN the least. The UK had a significantly shorter period for approval than the US and the shortest overall. The EU had the shortest period from the issuance of EUA to approval dates. Although not statistically significant, JP had the longest duration until unapproved drugs could be used. Pharmaceuticals granted usage permission under the EUA in JP, the EU, and the UK were developed or on the market in over 70% of cases, whereas in CN, more than two-thirds were yet to be developed. This suggests that CN may not actively utilize pharmaceuticals from other countries for COVID-19 treatment and may rely on its own. When comparing the emergency approval and permission systems of each country, the most significant difference was in the type of system granting approval.

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Conflict of interest statement

M.K. is an employee of Astellas Pharma Inc. Other authors have no conflicts of interest to declare. This does not alter our adherence to PLOS ONE policies on the sharing of data and materials.

Figures

Fig 1
Fig 1. Flowchart of drugs authorized for use under Emergency Use Authorization by FDA against COVID-19.
COVID-19: Coronavirus disease 2019, EUA: Emergency Use Authorization.
Fig 2
Fig 2. Review period of regulatory authority in each country for drugs authorized for use under Emergency Use Authorization by FDA against COVID-19.
The horizontal line in each box represents the median. The x mark represents the average values. The lines at the top and bottom edges of each box represent the 75th and 25th percentiles, respectively. The upper and lower limits of the vertical lines represent the maximum and minimum values, respectively. US: United States; JP: Japan; EU: Europe; UK: United Kingdom.
Fig 3
Fig 3. Period from the date of grant for Emergency Use Authorization to the date of approval in each country.
The horizontal line in each box represents the median. The x mark represents the average values. The lines at the top and bottom edges of each box represent the 75th and 25th percentiles, respectively. The upper and lower limits of the vertical lines represent the maximum and minimum values, respectively. JP: Japan, EU: Europe, UK: the United Kingdom.
See this image and copyright information in PMC

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