2008年10月20日のGCP研修会で、規制当局からEDCに関する信頼性調査の概要が発表されました。
厚労省ER/ES指針が発出されて3年半がたちますが、いよいよ本格的なER/ES査察が開始されることになります。
発表された信頼性調査チェックリストは、まだ改定と公式な発表が必要なようです。
したがって今すぐ査察が行われるわけではありません。
しかしながら、準備は早急にしておかなければなりません。
ER/ES指針（案）は、平成15年6月4日に厚生労働省医薬局審査管理課から発表されました。
この際には平成14年9月に米国ワシントンにて開催されたICH運営委員会において、eCTDがステップ4の3極合意に達したことをふまえ、医薬品等の承認又は許可に係る申請に関する記録等において電磁的記録及び電子署名を利用するための指針（案）を作成した旨の説明がありました。
つまり厚労省ER/ES指針は、もともとeCTDを実施する際の要件であったことがうかがえます。
パブリックコメントを電子メールによって提出する際のアドレスがectdshishin@mhlw.go.jpであったことからも推察できます。
しかしながら、eCTD申請受付が開始されてから3年半が経った現在でも、eCTDによる申請会社数は20社程度と伸び悩んでいます。
ただし申請数は増加していますので、同じ会社が繰り返しeCTDによる申請を行っていると推察されます。
もともとeCTDに向けて作成された厚労省ER/ES指針も、ふたを開けてみればその適用第1号は、EDCとなったわけです。
これまで書面調査は、原本を規制当局に持参していましたが、EDCにおけるeCRFのように電子記録が原本となるようなケースでは、査察官が製薬企業を訪問し調査することとなりました。
その理由は、監査証跡の確認です。
EDCにかぎらず、今後の査察では、製薬企業が電子的に作成した記録を、厚労省ER/ES指針に照らして調査を受けることが予想されます。
前回のメルマガや、論文等を通じて、タイプライターイクスキューズは通用しないことを繰り返し述べてきました。
いわゆるハイブリッドシステムでは、手書き署名や記名・捺印を紙媒体化したのみであり、記録は電子です。
したがって、紙媒体で承認を行ったとしても、けっして電子記録は削除してはなりません。
コンサルテーションをご提供している製薬企業で、よく次のような主張を聞きます。
「当社では、承認は責任者がすべてのプロセスを確認したうえで、紙媒体で行っている。したがって紙媒体が原本であり、正本である。」
つまり責任者が保証しているので、紙媒体が正しいと言いたいのであると思います。
しかしながら、世界の規制当局はその責任者を疑うのだということを知らなければなりません。
事故米や牛肉偽装問題など、世間を騒がせる事件のほとんどは、企業のトップの指示により実行されています。
査察直前に責任者が命じて電子記録を改ざんさせ、再度印刷の上で、承認を行ったとしたらどうでしょうか。
規制当局が電子記録の監査証跡を確認しなければ、改ざんは発見できないことになるでしょう。
EMEAのANNEX11改定案でも、紙媒体で査察を受ける場合は、監査証跡をすべて印刷しておくことを要求しています。
その場合でも、印刷された監査証跡が複雑である場合は、査察官はいつでも電子記録を直接参照できることを記述しています。
おそらくPart11の改定でも同様の要件が盛り込まれることでしょう。
今月末に日薬連主催の「医薬品GQP・GMP研究会」が開催され、その中で「コンピュータ化システムガイドライン」の概要が発表される予定です。
これは平成4年に発出され、平成17年3月30日に取り下げられた「コンピュータ使用医薬品等製造所適正管理ガイドライン（薬監第11号）」を改定するものです。
日本におけるCSVのガイドラインがどのように変更になるかが注目されます。
ある著名なEDCシステムでは、ユーザを無効化した際に監査証跡が消去されてしまうという、非常に大きな欠陥があります。
セキュリティ上、LPO（Last Patient Out：最終症例終了）の際には、当該医療機関のユーザを無効化しなければなりません。
その際には、無効化するのではなく、パスワードを変更するといった代替手段が望まれます。
規制当局が電子記録の査察を行った際に、見破れない不正行為が一つだけあります。
それはパスワードの漏えいです。
治験責任医師が他の者にパスワードを教え、電子署名を代わりに実行させたとしても、その事実はわかりません。
この行為は、実印を他人に預けることと同等です。決して許されません。
電子化がすすみ、便利になったとは言え、何事も利用する人たちのモラルにかかっていることは否めません。
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