改正GMP省令について

厚生労働省やPMDAの講演を聴いていると「承認事項遵守」といった発表が頻繁にある。
一度不正を行った企業は、これまで長期にわたってその企業名を講演会などで引用され、いわば人身御供のように取り扱われている。

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承認事項を遵守することは当然のことである。不正はけっしてあってはならない。

しかしである。世の中の(特に日本の)製薬企業でそれほどまでに不正が日常茶飯事に行われているのであろうか。
また承認事項さえ守っていれば、はたして品質の良い医薬品等が製造できるのであろうか。
そんなことはあるはずがない。
改正GMP省令の案の発出は予定よりも1年半も遅れている。最近では話題にも上がらないようになってきたようにも思える。
日本のGMP省令はPIC/S GMPなどグローバルの規制に比べて15年も遅れている。
これでは国際標準に到底追いつけない。
特定の企業の不正を執拗に糾弾するよりも、全体の品質保証レベルを上げる方が急務ではないだろうか。

https://www.youtube.com/watch?v=EbRHRlTQAEA&t=3s

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