CENTER FOR DRUG EVALUATION AND RESEARCH OFFICE OF COMPLIANCE 2021 ANNUAL REPORT

Assuring quality medicines are available to the American public
https://www.fda.gov/media/156272/download（参照 2022-06-21）
FDA CDER部局のコンプライアンス部門が2021年の活動報告を発出した
OPQ の概要と2021年の実績は；
・1,300+ OPQ Staff　(職員数;1300)
・9 OPQ Sub-Offices (分室)
・2 Locations(拠点): White Oak, MD and St. Louis, MO
・47 Pre-approval inspections conducted with OPQ staff<47件のPAI査察を実施＞」　
・21 Mission-critical inspections conducted with OPQ staff　＜21件の重要査察実施＞
・52% Reduction in the number of facilities needing pre-approval inspections by using alternative tools
　<52%のPAI を実施せずに他の方法で削減＞
・>90% of actions on time across all submissions with goal dates　＜90％以上、定刻で申請に対応＞
・617 Approved drug submissions to assist in treating patients with COVID-19
　<COVID-19の治療の申請617件を援助＞
・4 Approved biosimilars<4件のバイオシミラーを承認＞
・100 Approved complex generics <複合薬100件承認
・OPQ’s surveillance catalog comprises:  OPQの守備範囲
・>6,000 global drug manufacturers <世界中　6000の製造場所＞
・>135,000 approved application products 13500の承認済み医薬品
・>140,000 non-application products (e.g., over the counter, monograph, and homeopathic products
　140000品目以上の　申請が不要の製品
・130 OPQ research publications on topics including:130のOPQ公表され研究
　・Advanced manufacturing
　・COVID-19 therapeutics
　・Complex generic equivalence
　・Botanical products
　・Nanotechnology