いやくひんいりょうききそうごうきこうの英語

上記の事項は、「革新的医薬品・医療機器創出のための５か年戦略」（平成19 年4 月 内閣府・文部科学省・厚生労働省・経済産業省）においても、天然資源の少ない我が国が、優れた研究開発力をもとに、革新的医薬品・医療機器の国際的開発・提供体制へ参加していくとともに、日本で開発される革新的医薬品・ 医療機器の世界市場におけるシェアを拡大することで、医薬品・医療機器産業を日本の成長牽引役へ導くことが目標のひとつとされ、その実現のために臨床研究・治験環境の整備を施策に掲げ、この５カ年計画がその施策の重要な部分を担っていることを示している。例文帳に追加

The above mentioned items were also included as one of the goals in the "5-Year Strategy for the Creation of Innovative Pharmaceuticals and Medical Devices" (April 2007 Cabinet Office, Ministry of Education, Culture, Sports, Science and Technology, Ministry of Health, Labour and Welfare, and the Ministry of Economy, Trade and Industry) so that Japan, which has few natural resources, use its superior research and development abilities to participate in the global development and provision system of innovative pharmaceuticals and medical devices as well as expand the share of innovative pharmaceuticals and medical devices developed in Japan in the global market, thereby allowing the pharmaceutical and medical device industry to drive Japan's growth. Measures for the development of the clinical trial and clinical research environment required to realize this goal were set forth, and this 5-Year Plan plays an important part of these measures. - 厚生労働省

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

本ビジョン及び「革新的医薬品・医療機器創出のための５か年戦略」を強力に推進するため、厚生労働行政において、医薬品・医療機器の研究開発・実用化の促進や産業の国際競争力強化に係る体制を強化することとする。（2008 年度～） 医薬品産業が取り扱う医薬品は、国民の生命・健康に重大な影響を与え、医療保険財政との関わりも強いことから、一般の産業にもまして、高い倫理性、信頼性及び透明性が必要である。また、昨今、医薬品及び医薬品産業に対する国民の意識の変化が見られ、成長産業として政府の期待感が示されるなど、これまでになく医薬品産業に注目が集まっており、より一層の公正な企業行動、開かれた企業体質、企業倫理の遵守など、国民の信頼を裏切らないように努めることが求められている。行政としても、国民に世界最高水準の医薬品が迅速に提供されるよう、医薬品産業を支援するとともに、国民の視点に立った施策を進めていくことが必要である。例文帳に追加

To push ahead with this Vision and the 'Five-Year Strategy for the Creation of Innovative Drugs and Medical Devices' the Health, Labour and Welfare administration shall consolidate the framework for promoting drug and medical device research and commercialization and for enhancing the global competitiveness of the industry. (Fiscal 2008 ~ )ConclusionSince the drugs supplied by the drug industry have a major impact on the life and health of the nation and also have a bearing on medical insurance finances, an even higher level of ethics, reliability and transparency is called for from this industry than from industries in general. Further, the drug industry is now attracting unprecedented attention, as evidenced last year by the changes in the national perception of drugs and the industry and the expectations placed on it by the government as a growth industry. Greater political correctness in corporate behaviour, an open business structure, compliance with the code of practices and other efforts to maintain the trust of the public are called for. The government should also support the drug industry and implement public-focused policies to ensure the prompt delivery of world-leading drugs to the nation. - 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

2007 年 1 月 31 日に、厚生労働大臣主催のもと、文部科学大臣・経済産業大臣、製薬業界、教育・研究機関の関係者等が参集し、医薬品分野のイノベーション創出と医薬品産業の国際競争力の強化について共通認識を持つことを目的として、「革新的医薬品のための官民対話」を設置した。さらに、2007 年 4 月 26 日に 2 回目の官民対話を行い、この場で「革新的創薬のための医薬品・医療機器創出のための５か年戦略」を決定した。今後は、年 1～2 回のペースで官民対話を実施するとともに、定期的に、５か年戦略について進捗状況を確認していくこととしている。（2007 年度～）例文帳に追加

On January 31 2007 hosted by the Minister of Health the 'Public-private dialogue for innovative drugs' was inaugurated and attended by the Minister of Education, Culture, Sports, Science and Technology, the Minister of Economy, Trade and Industry and representatives from the pharmaceutical industry and educational and research institutions etc. The aim of the dialogues is to gain a common perception on the creation of innovation in the drug field and enhancement of the global competitiveness of the drug industry. A second public-private dialogue was also held, on April 26 2007, at which the 'Five-Year Strategy for the Creation of Innovative Drugs and Medical Devices' was agreed. These dialogues shall continue to be held around once or twice a year, and progress checks on the Five-Year Strategy shall be carried out regularly. (Fiscal 2007 ~ ) - 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

これまでも内閣総理大臣の主導あるいは関係閣僚等の協力により様々な取組が行われてきたが（2002年12月の「バイオテクノロジー戦略大綱」（小泉総理時策定）、2004年 5 月の「健康フロンティア戦略」（与党幹事長・政調会長会議）など）、昨今、内閣総理大臣が経済成長に貢献するイノベーションの創出に資する分野として医薬分野を第一に例示するなど、医薬品産業への期待は高まってきており、2007 年には「新健康フロンティア戦略」、「イノベーション２５」（いずれも安倍総理時）が策定された。「革新的医薬品・医療機器創出のための５か年戦略」についても、政府全体の方針として位置付けられている。例文帳に追加

In the past, various efforts were engaged under the initiative of the prime minister or the cooperation with Cabinet members (“Strategic outline of biotechnology” in December, 2002 (established during the Koizumi’s administration)), “Strategy of health frontier” (such as secretary general of the ruling parties/ chairman of the Policy Research Council)), and there are great expectations toward the pharmaceutical industry that in recent years, the prime minister firstly illustrated the medical fields as an example for the filed that benefits the development of innovation contributing to the economic growth. In 2007, “”New strategy of health frontier” and “Innovation 25” (both established during the Abe’s administration) were established. “5 years strategy for development of innovative pharmaceutical products / medical devices” was placed as the policy of the whole government. - 厚生労働省