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行政資料
- 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
- GOOD PRACTICES FOR DATA MANAGEMENT AND INTEGRITY IN REGULATED GMP/GDP ENVIRONMENTS 2018/11/30
- 事務連絡「点眼剤の後発医薬品の生物学的同等性試験実施に関する基本的考え方について」 2018/11/29
- ICH Press Release Charlotte, NC, USA, November 2018 Advancement of Harmonisation Efforts in an Increasingly Global ICH 2018/11/23
- Guideline on the quality of water for pharmaceutical use Draft 2018/11/15