- PTJ ONLINE トップ
- 行政資料
行政資料
- WHO「DRAFT WORKING DOCUMENT FOR COMMENTS: Good manufacturing practices for investigational products」 2020/11/10
- FDA "Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency" 2020/09/10
- PIC/S AUDIT CHECKLIST - INTERPRETATION GUIDE 2020/09/01
- FDA "Control of Nitrosamine Impurities in Human Drugs" 2020/09/01
- 事務連絡「Ｎ－ニトロソジメチルアミンが検出されたラニチジン塩酸塩製剤又はニザチジン製剤の使用による健康影響評価の結果等について」 2020/09/01
- FDA "Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers Guidance for Industry" 2020/08/19
- FDA ”Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR 320.38(c) Guidance for Industry” 2020/08/18
- 製造販売業者及び製造業者の法令遵守に関するガイドライン 2020/08/11
- 事務連絡「医薬品添加物の使用前例調査の結果について」 2020/07/31
- EMA "Guideline on the quality of water for pharmaceutical use" 2020/07/20