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行政資料
- FDA, Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act 2018/05/10
- 薬生薬審発0510 第２号「医療用医薬品の有効成分の要指導・一般用医薬品への転用について」 2018/05/10
- EMA, "PRIME: a two-year overview" 2018/05/07
- FDA, "Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017 Guidance for Industry" 2018/05/02
- FDA, "Requests for Expedited Review of New Drug Application and Biologics License Application Prior Approval Supplements Submitted for Chemistry, Manufacturing, and Controls Changes" 2018/04/23
- 薬生発0418第4号「医薬品の範囲に関する基準の一部改正について」 2018/04/19
- Report on the International Active Pharmaceutical Ingredient Inspection Programme 2011 – 2016 2018/04/12
- 薬生監麻発0410第1号「医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法」 2018/04/10
- 医政経発0410第1号「薬事工業生産動態統計調査の調査方法の変更について（通知）」 2018/04/10
- E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population Guidance for Industry 2018/04/10