「医薬品医療機器総合機構」に関連した英語例文の一覧と使い方 - Weblio英語例文検索

承認審査の迅速化と体制強化のため、（独）医薬品医療機器総合機構を設立、審査員の計画的増員を図るとともに、審査事務処理期間の短縮目標を設定し、透明性の高い審査を実施してきた。また、医療の必要性の高い医薬品の優先的な治験相談も実施している。例文帳に追加

The Pharmaceuticals and Medical Devices Agency was established and systematic review staff increases planned to expedite approval reviews and reinforce the system. In addition, targets for reducing the administrative processing time for reviews were set and reviews have been conducted with a high degree of transparency. Furthermore, priority clinical trial consultations are also held for drugs highly needed in medical care. - 厚生労働省

日本版バイ・ドール制度の導入を含め、ベンチャー企業や製薬企業等に技術移転された研究成果を含めた最先端の研究成果の実用化研究を（独）医薬基盤研究所（2004年度は（独）医薬品医療機器総合機構）において委託研究事業として実施している。例文帳に追加

In addition to the introduction of a Japanese version of the Bayh-Dole system, the Institute of Basic Pharmaceutical Research (from fiscal 2004 the Pharmaceuticals and Medical Devices Agency) has been conducting contract research projects to commercialize the outcomes of advanced research including those given to venture firms and pharmaceutical companies etc. through technology transfers. - 厚生労働省

（独）医薬品医療機器総合機構で実施している治験相談や承認審査の体制に関しては人材不足、特に適切で効率的な審査に資する人材や臨床経験のある医師及び生物統計家の不足が指摘されており、治験相談や承認審査の遅延の要因の一つと考えられている。その解消を図り、治験相談や承認審査の迅速化・効率化を図るため、例文帳に追加

It has been pointed out that the framework for the clinical trial consultations and approval reviews conducted by the Pharmaceuticals and Medical Devices Agency lacks human resources, in particular those that will promote approval efficiency and physicians and biostatisticians with clinical experience. This is held to be one of the reasons for the delays in clinical trial consultations and approval reviews. The following measures are necessary to solve this problem and to expedite and promote the efficiency of clinical trial consultations and approval reviews: - 厚生労働省

（独）医薬品医療機器総合機構により行われる治験相談について、欧米並みに希望通りに治験相談が行われていない状況にあり、また、相談内容も企業の満足が十分得られているとは言えず、企業活動上必要とされる適時的確な治験相談体制とは乖離した状況である。例文帳に追加

The clinical trial consultations conducted by the Pharmaceuticals and Medical Devices Agency are not on a level with those in Europe and the US as expected. Their content also cannot be described as fully satisfactory to the companies concerned and the system is far from being the timely and precise one needed for corporate operations. - 厚生労働省

このような治験相談体制について、全ての治験相談にタイムリーに対応可能な相談体制の構築のため、（独）医薬品医療機器総合機構において、新たな審査・相談体制に向けたガイダンスの整備、相談可能件数枠の大幅増加、申し込み待ち時間の短縮、相談メニューの拡充、申請内容の事前評価も含めた新たな相談・審査体制の導入等を目標に掲げ、取組を進めることとしている。（2008 年度～）例文帳に追加

To establish a clinical trial consultation system capable of timely responses to all consultations, the Pharmaceuticals and Medical Devices Agency shall take initiatives to set targets including guidance for a new consultation and review framework, a substantial increase in the consultations quota, reduction in the application waiting time, improved consultation options and preliminary evaluation of application details. (Fiscal 2008 ~ ) - 厚生労働省

第三十二条　農林水産大臣、経済産業大臣又は厚生労働大臣は、前条第一項の場合において必要があると認めるときは、独立行政法人農林水産消費安全技術センター、独立行政法人種苗管理センター、独立行政法人家畜改良センター、独立行政法人水産総合研究センター、独立行政法人製品評価技術基盤機構又は独立行政法人医薬品医療機器総合機構（以下「センター等」という。）に対し、次に掲げるセンター等の区分に応じ、遺伝子組換え生物等の使用等をしている者、又はした者、遺伝子組換え生物等を譲渡し、又は提供した者、国内管理人、遺伝子組換え生物等を輸出した者その他の関係者がその行為を行う場所その他の場所に立ち入らせ、関係者に質問させ、遺伝子組換え生物等、施設等その他の物件を検査させ、又は検査に必要な最少限度の分量に限り遺伝子組換え生物等を無償で収去させることができる。例文帳に追加

Article 32 (1) The Minister of Agriculture, Forestry and Fisheries, the Minister of Economy, Trade and Industry or the Minister of Health, Labour and Welfare may, when recognizing it necessary in cases listed in paragraph (1) of the preceding Article, Food and Agricultural Materials Inspection Center (Incorporated Administrative Agency), the National Center for Seeds and Seedlings (Incorporated Administrative Agency), the National Livestock Breeding Center (Incorporated Administrative Agency), the Fisheries Research Agency (Incorporated Administrative Agency), the National Institute of Technology and Evaluation (Incorporated Administrative Agency) or the Pharmaceuticals and Medical Device Agency (Incorporated Administrative Agency) (hereinafter referred to as "Centers"), in accordance with the categories of Centers listed below, to enter premises where a person who has used or is using living modified organisms, a person who has transferred or supplied living modified organisms, a Domestic Administrator, a person who has exported living modified organisms, or other relevant persons carry out such acts, or other places, and there to question relevant persons, inspect living modified organisms, Facilities, and other properties, or remove living modified organisms, at no cost, limited to the minimum amount necessary for inspection.  - 日本法令外国語訳データベースシステム