規制要件とは

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超入門者のためのページです。

*万が一文中に解釈の間違い等がありましても、当社では責任をとりかねます。
 本文書の改訂は予告なく行われることがあります。

日本は民主主義国家であり、法治国家である。
三権分立が憲法で定められている。
まず法律(たとえば薬事法)は、国会の議決を経て制定される。(立法)
国会は国権の最高機関であり、国民から正当に選挙された議員によって運営される。
法律を実際に施行するのが各省庁である。(行政)
各省庁では、法律を施行するための規則である省令を定める。
省令とは、命令のひとつであり、各省の大臣が主任の行政事務について、法律若しくは政令を施行するため、又は法律若しくは政令の特別の委任に基づいて発する成文法をいう。
厚生労働大臣が定めるものが厚生労働省令である。省令は省ごとに固有の法令番号(省令番号)を持つ。
省令は、特に題名を持たず制定年と省令番号のみ(あるいは件名)で呼ばれる省令もあるが、固有の名前(題名)が付けられているものが多い。省令には特定の法律から委任された規定及び特定の法律を施行するのに必要な規定をまとめて制定したものが多くあり、そのような省令はその法律の「~施行規則」などと命名されることが多い。
省令を施行する中で、局長通知、課長通知、事務連絡等が発出される。
省令に基づき査察が実施され、(公務員には不正等の告発の義務があり)重大な違反が発見された場合には、検察当局に告発を行う。告発された事案は、法律(たとえば薬事法)に基づき、裁判所において裁かれる。(司法)

法令と規制要件

薬事法は、米国ではFederal Food and Cosmetic Act(FDC法)に相当する。
省令は、米国ではCode of Federal Regulations(CFR)に相当する。
通知は、米国ではGuidanceやGuidelineに相当する。

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