The number of global clinical trials including Japan is increasing but still 
much lower than those including the USA and Europe. The regulatory requirements 
for clinical trials have been harmonized among Japan, USA, and Europe, and the 
quality of clinical trials is kept high in these regions. Xofluza (baloxavir 
marboxil) for influenza approved in Japan under the SAKIGAKE Designation System 
is a good example of clinical trials including Japan. To include Japan in more 
global clinical trials, stakeholders should work more collaboratively, and 
increase the perception that clinical trials can be conducted appropriately and 
efficiently in Japan. Further measures for better management of clinical trials 
should also be developed. These would ultimately lead to improved benefits for 
patients with timely access to new drugs.