抄録
Countermeasures against bioterrorism have increased
since September 11 and anthrax attacks in the United
States of America in 2001. The “Strategy to Make Japan
the Safest Country in the World” was approved by the
Cabinet in 2013. Strengthening countermeasures against
naturally-occurring infectious disease outbreaks implies
strengthening countermeasures against bioterrorism;
however, the latter bears particular challenges. One of these
challenges is the approval of counter-terrorism therapeutic
or prophylactic agents, since the use of these agents is rare.
To move up the market for innovative drug candidates, the
“SAKIGAKE” designation scheme was introduced on a
pilot basis by the Ministry of Health, Labour and Welfare
in 2015. It is hoped that this scheme will be also applicable
for counter-terrorism agents.
