医薬品の「緊急承認」可能に　改正薬機法が成立

　感染症拡大時などにワクチンや治療薬などを「緊急承認」する制度の創設を盛り込んだ改正医薬品医療機器法が、１３日の参院本会議で全会一致で可決、成立した。臨床試験（治験）完了前でも、安全性を確認した上で有効性が推定できれば、薬事承認が可能となる。（2022/05/13-12:25）

The Diet, Japan's parliament, on Friday enacted a bill to create a system granting emergency regulatory approval to vaccines, drugs and other medical goods in urgent situations such as when an infectious disease is spreading.
   The bill to amend the pharmaceuticals and medical devices law was approved unanimously at a plenary meeting of the House of Councillors, the upper chamber of the Diet, on the day. The amendment cleared the House of Representatives, the lower chamber, earlier.
   Under the system, regulatory approval would be given to drugs and vaccines even before the completion of clinical trials if their safety is confirmed and their effectiveness can be estimated.
   The establishment of the system comes after Japan lagged behind the United States and European countries in putting COVID-19 vaccines to practical use.
   Vaccines that are being distributed overseas and estimated to be effective, for example, can be given emergency approval without clinical trials in Japan, enabling quicker distribution than under the current special pharmaceutical approval system.