noun
regulatory approval of a drug or medical device
Formal term used in pharmaceutical and medical device regulation contexts.
新薬の薬事承認が下りた。
The new drug received regulatory approval.
薬事承認を得るには臨床試験が必要だ。
Clinical trials are necessary to obtain regulatory approval.
General term for approval or recognition; 薬事承認 specifically refers to pharmaceutical regulatory approval.
Compound of 薬事 (pharmaceutical affairs) and 承認 (approval).