『医療機器の臨床試験のタイミング』

工程設計に関する製薬規制と医療機器規制の違い

最近、製薬企業が医療機器に進出し、筆者のもとにコンサルティングの依頼が舞い込むことがしばしばある。
その際に医療機器の臨床試験実施のタイミングと治験医療機器の製造に関する質問を多く受ける。
まず第一に、製薬規制と医療機器規制では、研究開発と臨床試験の実施順序が大きく異なる。
医薬品では、開発において臨床試験を実施したのち、製造所への技術移転すなわち工業化（スケールアップ）がCMC部門によって実施される。
また治験薬はGMP（本邦においては治験薬GMP）に準拠して製造しなければならない。
一方で医療機器は、開発が終了し量産化（工程設計）が完了してから臨床試験が設計バリデーションの一環として実施される。すなわちプロセスバリデーションの実施が先であり、設計バリデーションの実施が後である。 

つまり臨床試験を含む設計バリデーションは、量産機（または量産相当機）で実施しなければならない。
医薬品のような治験薬GMPに相当する規則はない。
量産機（または量産相当機）を用いて臨床試験を実施する際には、実際の製造所において製造しなければならない。（一部例外はある。）
製造所は医薬品規制とは異なり、製造所許可を取得しておく必要はない。医療機器製造所は登録制である。

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