[Data Link] GMP – ID6517 [2020/01/09]
ICH Q12
https://www.gmp-compliance.org/gmp-news/ich-q12-adopted
ICH Q12
https://www.ich.org/page/quality-guidelines#12
EMA “Non-Compliance Report” as same as FDA “Warning Letter”
https://www.gmp-compliance.org/gmp-news/is-there-anything-like-european-warning-letters
EudraGMDP database
http://eudragmdp.ema.europa.eu/inspections/gmpc/searchgmp noncompliance.do
EMA – Medical Devices regulation (MDR)
https://www.gmp-compliance.org/gmp-news/information-on-the-medical-devices-regulation
FDA – コンビネーション製品の承認
https://www.gmp-compliance.org/gmp-news/how-to-authorize-a-combination-product-in-the-usa
FDA – Principles of Premarket Pathways for Combination Products Guidance for Industry and FDA Staff
https://www.fda.gov/media/119958/download
EMA – GDPに関する新Aide Memoire
1. 卸売業者は指定された業者であるか
2. 偽造と疑われ医薬品に関する
https://www.gmp-compliance.org/gmp-news/falsified-medicines-new-eu-aide-memorire-for-gdp
用語の解説リンク、関連投稿および広告
EMA
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FDA
[用語] CDER; The Center for Drug Evaluation and Research; FDA医薬品評価研究所センター – ID21953
[用語] FDA483
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GMP
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