日欧米三極におけるＧＭＰ【システム】査察とGMP体制の違い

It has been my interest to know the difference of GMP systems among USA, EU and Japan.

According to Mr Yasumoto:

" The impression was that PMDA (Japanese authorities) is not as demanding as FDA. However, PMDA seems to be very strict for biopharmaceuticals and analytical procedures. PIC/s is similar to WHO and FDA, while some particular analytical methods are required."

@Asian_API 日本のPMDAはFDAのシステム査察よりは甘い印象がある反面、バイオ医薬や試験法には非常に厳格なイメージがあります。PIC/SはWHOとFDAとほぼ同じですが、一部独自の試験法が要求されている感じ。でしょうか？140字だとなかなか説明は難しいですね。less than a minute ago via HootSuiteAtsushi Yasumoto
Atsu_4

参考：FDAとEMEAの相違点　査察官特別講演ｐ４８

In EU, Germany has special regulation for biological /fermentation products while other European countries don't. Still, fermentation products like statins or immunosuppressants are not as difficult as protein drugs.