Part11のゆくえ!?

当社のホームページでもお知らせしましたように、FDAが6/11に開催を予定していたPart11 Public Meetingが中止となりました。
中止の理由は、たてまえ上、故レーガン元大統領の国葬により政府機関が臨時休暇とされたためです。
しかしながら、再開催を予定していないことからもわかるように、実際には開催したとしても更に混乱を増すばかりであると推察できます。
Part11を改定し、本格的に実施したいFDAに対して、全面的にPart11廃止を要求する業界側とでは、全く意見が対立しています。
このままでは、公開討論を行っても収集がつかないのは明らかでしょう。
いったいFDAの意図はどこにあるのか、またPublic Meetingに何を求めて、どこにゴールをおいているのかがよくわかりません。
一方、”日本版Part11″である「医薬品等の承認又は許可に係る申請に関する電磁的記録・電子署名利用のための指針」は、本家のPart11がこんな状態ですから、なかなか出せないのが実情でしょう。
ところが、eCTDは来年4月から受付が開始されることになりましたから、その前提となる”日本版Part11″はそれまでに発行しなければなりません。
今後、日米両国における電子記録に関する規制要件がどの方向へ向かうのかは、混迷を極めるように思われます。

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