ワクチンや治療薬、有効性推定で「緊急承認」　法改正案を閣議決定

　政府は１日、新型コロナウイルス流行など緊急時に、ワクチンや治療薬などの有効性が推定できれば薬事承認できる「緊急承認」創設を盛り込んだ医薬品医療機器法改正案を閣議決定した。コロナワクチンの実用化が欧米より遅れた反省から、手続きの迅速化を目指す。医薬品の国内開発を強化する狙いもある。
　緊急承認では、海外製の医薬品は国内での臨床試験（治験）前、国内開発では最終治験前でも、安全性を確認した上で有効性が推定できれば承認し、販売できる。
　実用化から約２年以内に有効性が確認できない際は、承認を取り消す。健康被害が起きた場合は、現行と同じ救済制度で医療費などを支払う。（2022/03/01-08:44）

The Japanese government Tuesday adopted a bill to enable rapid pharmaceutical approvals of vaccines and drugs considered effective, in emergency situations including when the novel coronavirus is spreading.
   The bill to revise the pharmaceuticals and medical devices law is aimed at speeding up related procedures after Japan lagged behind the United States and Europe in putting COVID-19 vaccines into practical use. It is also designed to strengthen the domestic development of medical products.
   The planned emergency approval system will allow medicines and other medical products used overseas to be sold in Japan before clinical trials if their safety is confirmed and their effectiveness is expected.
   Under the system, domestically developed products will be allowed to be used before their final clinical trials under the same conditions.
   The government will revoke the approvals if it turns out the medical products have no effects within two years of the start of practical use.