- PTJ ONLINE トップ
- 行政資料
行政資料
- Concept Note on a Document prepared by the PIC/S QRM Expert Circle on ‘How to Evaluate / Demonstrate the Effectiveness of a Pharmaceutical Quality System in relation to Risk-based Change Management 2019/11/28
- 事務連絡「GMP、QMS及びGCTPのガイドラインの国際整合化に関する研究成果の配布について」 2019/11/28
- ICH Press Release "Singapore November 2019 Continued Advancement in Global Harmonisation Efforts as ICH Prepares for 30 Year Commemoration" 2019/11/27
- FDA "Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insul in Products" 2019/11/25
- WHO "GUIDELINE ON DATA INTEGRITY" 2019/11/20
- FDA "Transdermal and Topical Delivery Systems - Product Development and Quality Considerations" 2019/11/20
- EMA "Annual activity report 2018" 2019/11/12
- EMA Regulatory Science to 2025 Five goals for human medicines regulation 2019/11/11
- FDA "Drug Shortages: Root Causes and Potential Solutions" 2019/10/29
- FDA "Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software" 2019/10/28