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行政資料
- 医薬品の適正流通(GDP)ガイドライン 2018/12/28
- 事務連絡「再生医療等製品の不具合等報告に係る運用について」 2018/12/20
- EMA Regulatory Science to 2025 2018/12/19
- EMA "Draft guideline on quality and equivalence of topical products" 2018/12/14
- EMA "Guideline on Active Substance Master File Procedure" 2018/12/14
- 日本薬局方外生薬規格 2018 2018/12/14
- 薬生薬審発1214第1号「日本薬局方外生薬規格2018 について」 2018/12/14
- Data Integrity and Compliance With Drug CGMP Questions and Answers Guidance for Industry 2018/12/12
- EMA ”Mobile scanning and other technologies in the labelling and package leaflet of centrally authorised medicinal products” 2018/12/07
- EMA "Guideline on the environmental risk assessment of medicinal products for human use” 2018/11/30