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

by Kazuki Edo, Masahide Kawano, Hideki Maeda

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.