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行政資料
- FDA "Abbreviated New Drug Application Submissions--Amendments to Abbreviated New Drug Applications Under the Generic Drug User Fee Act" 2018/07/03
- 事務連絡「医薬品添加物規格2018の正誤表」 2018/06/27
- 薬生薬審発0627第1号「「潜在的発がんリスクを低減するための医薬品中DNA反応性（変異原性） 不純物の評価及び管理ガイドラインについて」の一部改正について」 2018/06/27
- 薬生薬審発0627第１号「「潜在的発がんリスクを低減するための医薬品中DNA反応性（変異原性）」 2018/06/27
- Health Canada, "Notice to industry: Aligned reviews between Health Canada and health technology assessment organizations" 2018/06/22
- PIC/S "GUIDELINE ON SETTING HEALTH BASED EXPOSURE LIMITS FOR USE IN RISK IDENTIFICATION IN THE MANUFACTURE OF DIFFERENT MEDICINAL PRODUCTS IN SHARED FACILITIES" 2018/06/21
- PIC/S "GUIDELINES ON THE PRINCIPLES OF GOOD DISTRIBUTION PRACTICE OF ACTIVE SUBSTANCES FOR MEDICINAL PRODUCTS FOR HUMAN USE" 2018/06/20
- PIC/S "GUIDELINES ON THE FORMALISED RISK ASSESSMENT FOR ASCERTAINING THE APPROPRIATE GOOD MANUFACTURING PRACTICE FOR EXCIPIENTS OF MEDICINAL PRODUCTS FOR HUMAN USE" 2018/06/20
- AIDE-MEMOIRE on CROSS-CONTAMINATION IN SHARED FACILITIES 2018/06/20
- PIC/S GMP Guide Part 1 (PE 009-14) 2018/06/20