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　　推進(jìn)藥品監(jiān)管科學(xué)，是當(dāng)今世界藥品監(jiān)管機(jī)構(gòu)實(shí)現(xiàn)藥品監(jiān)管現(xiàn)代化的重大戰(zhàn)略選擇。在推進(jìn)藥品監(jiān)管科學(xué)發(fā)展中，美國(guó)和歐盟分別制定了藥品監(jiān)管科學(xué)戰(zhàn)略，從全局和戰(zhàn)略上規(guī)劃藥品監(jiān)管科學(xué)發(fā)展的目標(biāo)、重點(diǎn)和方向等。2010年10月美國(guó)健康和人類服務(wù)部（HHS）、美國(guó)食品藥品管理局（FDA）聯(lián)合發(fā)布《推進(jìn)公共健康的監(jiān)管科學(xué)：FDA監(jiān)管科學(xué)行動(dòng)計(jì)劃框架》；2011年8月FDA發(fā)布《推進(jìn)監(jiān)管科學(xué)：戰(zhàn)略規(guī)劃》；2013年7月FDA發(fā)布《推進(jìn)藥品監(jiān)管科學(xué)的戰(zhàn)略及實(shí)施方案》。2020年3月，歐洲藥品監(jiān)督管理局（EMA）發(fā)布《監(jiān)管科學(xué)2025：戰(zhàn)略思考》。現(xiàn)選取部分精彩論述，供參考：

一、2010年10月HHS、FDA《推進(jìn)公共健康的監(jiān)管科學(xué)：FDA監(jiān)管科學(xué)行動(dòng)計(jì)劃框架》

　　1.監(jiān)管科學(xué)是指開發(fā)評(píng)估FDA監(jiān)管產(chǎn)品的安全性、有效性、質(zhì)量和性能的新工具、新標(biāo)準(zhǔn)和新方法的科學(xué)。

　　Regulatory science is the science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products.

　　2.沒(méi)有一個(gè)發(fā)現(xiàn)—沒(méi)有神奇的子彈—能解決我們獨(dú)特的現(xiàn)代科學(xué)監(jiān)管挑戰(zhàn)。但有一點(diǎn)是明確的：如果我們要解決我們今天面臨的最緊迫的公共健康問(wèn)題，我們需要新的方法、新的合作和新的方式，以利用21世紀(jì)的技術(shù)。我們現(xiàn)在就需要它們。

　　There is no single discovery — no magic bullet — to address our unique set of modern scientific regulatory challenges. But one thing is clear: if we are to solve the most pressing public health problems we face today, we need new approaches, new collaborations and new ways to take advantage of 21st century technologies. And we need them now.

　　3.監(jiān)管科學(xué)的進(jìn)步將有助于提高審評(píng)審批效率，幫助更快地向患者提供安全的新產(chǎn)品，并加強(qiáng)監(jiān)測(cè)產(chǎn)品使用和提高性能的能力，從而提高患者的治療效果。

　　Advances in regulatory science will help make the evaluation and approval process more efficient, helping to deliver safe new products to patients faster and strengthening the ability to monitor product use and improve performance, thus enhancing patient outcomes.

　　4.如果沒(méi)有監(jiān)管科學(xué)的進(jìn)步，有希望的醫(yī)療方法可能就會(huì)僅僅因?yàn)槲覀內(nèi)狈φJ(rèn)識(shí)其潛力的工具而在研發(fā)過(guò)程中被拋棄，或者過(guò)時(shí)的評(píng)估方法可能不必要地推遲其批準(zhǔn)。相反，無(wú)數(shù)的金錢和時(shí)間可能被浪費(fèi)在評(píng)估一種之后被證明不安全或無(wú)效的新的療法上。

　　Without advances in regulatory science, promising medical therapies may be discarded during the developmental process simply because we lack the tools to recognize their potential, or outdated evaluation methods may unnecessarily delay their approval. Conversely, countless dollars and years may be wasted assessing a novel therapy that is later shown to be unsafe or ineffective.

　　5.監(jiān)管科學(xué)的進(jìn)展不僅可以保證更好的質(zhì)量，還可以降低開發(fā)和生產(chǎn)成本。

　　Advances in regulatory science will not only ensure better quality, but could also lower development and manufac turing costs.

二、2011年8月FDA《推進(jìn)監(jiān)管科學(xué)：戰(zhàn)略規(guī)劃》

　　1.FDA的決策制定必須基于現(xiàn)有最佳科學(xué)數(shù)據(jù)，并使用現(xiàn)有的最佳工具和最佳方法，以確保產(chǎn)品符合消費(fèi)者的最高質(zhì)量標(biāo)準(zhǔn)，同時(shí)還要促進(jìn)和推動(dòng)其所監(jiān)管產(chǎn)品的創(chuàng)新。

　　FDA must make decisions based on the best available scientific data and using the best tools and methods available in order to ensure products meet the highest quality standards for consumers, while at the same time fostering and advancing innovation in the products it regulates.

　　2.在過(guò)去的幾年里，創(chuàng)新科學(xué)的迅速發(fā)展為新藥的發(fā)現(xiàn)、生產(chǎn)和評(píng)估以及食品安全和質(zhì)量的提高提供了新的技術(shù)；FDA必須跟上并利用這些新的科學(xué)進(jìn)展，以完成其保護(hù)和促進(jìn)國(guó)民健康的使命。

　　In the last few years, rapid advances in innovative science have provided new technologies to discover, manufacture and assess novel medical products, and to improve food safety and quality; FDA must both keep pace with and utilize these new scientific advances in order to accomplish its mission to protect and promote the health of our nation.

　　3.FDA的科學(xué)家必須在一個(gè)培養(yǎng)創(chuàng)造性思維、促進(jìn)科學(xué)多學(xué)科互動(dòng)與協(xié)作、提供學(xué)習(xí)機(jī)會(huì)、確保科學(xué)卓越性和完美性、提供最先進(jìn)的實(shí)驗(yàn)室和計(jì)算機(jī)技術(shù)以供使用的環(huán)境中工作。

　　FDA scientists must work in an environment that fosters creative thinking, promotes scientific multidisciplinary interaction and collaboration, offers opportunities for learning, ensures both scientific excellence and integrity, and provides access to state-of-the-art laboratory and computer technologies.

　　4.FDA監(jiān)管科學(xué)戰(zhàn)略規(guī)劃確定了關(guān)鍵優(yōu)先領(lǐng)域和活動(dòng)，在這些領(lǐng)域FDA有必要采取新的或強(qiáng)化的措施來(lái)參與監(jiān)管科學(xué)研究，這對(duì)保持其使命的持續(xù)成功至關(guān)重要。

　　The FDA Strategic Plan for Regulatory Science identifies critical priority areas and activities where new or enhanced engagement in regulatory science research is essential to continued mission success.

　　5.這項(xiàng)監(jiān)管科學(xué)規(guī)劃的成功實(shí)施，包括不同利益相關(guān)者的參與，將使FDA在完成今天監(jiān)管使命的同時(shí)也為迎接明天的新挑戰(zhàn)做好了準(zhǔn)備。

　　Successful implementation of this regulatory science plan, including engagement with diverse stakeholders, will allow the Agency to fulfill its regulatory mission today while also being prepared for the new challenges of tomorrow.

三、2013年7月FDA《推進(jìn)藥品監(jiān)管科學(xué)的戰(zhàn)略及實(shí)施方案》

　　1.藥品監(jiān)管科學(xué)的作用是開發(fā)必要的知識(shí)、方法、標(biāo)準(zhǔn)和工具，以提高監(jiān)管決策的確定性、一致性，促進(jìn)基礎(chǔ)發(fā)現(xiàn)轉(zhuǎn)化為切實(shí)可用的藥品。

　　The role of regulatory science with respect to medical products is to develop the knowledge, methods, standards, and tools needed to increase the certainty and consistency of regulatory decisions and improve the translation of basic discoveries to viable medical products.

　　2.FDA通過(guò)使用科學(xué)標(biāo)準(zhǔn)來(lái)評(píng)估藥品在整個(gè)生命周期中的安全性、有效性和質(zhì)量，從而促進(jìn)公眾健康。

　　FDA advances the public health by applying scientific standards to assess the safety, efficacy, and quality of medical products throughout the product lifecycle.

　　3.FDA將推進(jìn)監(jiān)管科學(xué)，以加快創(chuàng)新，改進(jìn)監(jiān)管決策，并將產(chǎn)品提供給需要的人。21世紀(jì)的監(jiān)管科學(xué)將成為FDA與不同合作伙伴協(xié)作，保護(hù)和促進(jìn)我們國(guó)家和全球社會(huì)健康的推動(dòng)力。

　　FDA will advance regulatory science to speed innovation, improve regulatory decision-making, and get products to people in need. 21st Century regulatory science will be a driving force as FDA works with diverse partners to protect and promote the health of our nation and the global community.

四、2020年3月EMA《監(jiān)管科學(xué)2025：戰(zhàn)略思考》

　　1.監(jiān)管科學(xué)是指應(yīng)用于藥品質(zhì)量、安全性和療效評(píng)估的一系列科學(xué)學(xué)科，并在藥品的整個(gè)生命周期內(nèi)為管理決策提供信息。它包括基礎(chǔ)和應(yīng)用生物醫(yī)學(xué)以及社會(huì)科學(xué)，旨在開發(fā)監(jiān)管標(biāo)準(zhǔn)和工具。

　　Regulatory science is defined as the range of scientific disciplines that are applied to the quality, safety and efficacy assessment of medicinal products and that inform regulatory decision-making throughout the lifecycle of a medicine. It encompasses basic and applied biomedical and social sciences and contributes to the development of regulatory standards and tools.

　　2.近些年，創(chuàng)新步伐急劇加速，越來(lái)越多的藥物通過(guò)整合不同技術(shù)而提供醫(yī)療解決方案，監(jiān)管機(jī)構(gòu)需要做好準(zhǔn)備，以支持日益復(fù)雜的藥物研發(fā)，促進(jìn)和保護(hù)人類和動(dòng)物健康。

　　The pace of innovation has accelerated dramatically in recent years and regulators need to be ready to support the development of increasingly complex medicines that more and more deliver healthcare solutions by converging different technologies to promote and protect human and animal health.

　　3.為強(qiáng)化其保護(hù)人類健康的使命，EMA必須助力推動(dòng)監(jiān)管科學(xué)和創(chuàng)新轉(zhuǎn)化為不斷發(fā)展的醫(yī)療體系中患者對(duì)藥物的可及性。

　　To underpin its mission of protecting human health, EMA must catalyse and enable regulatory science and innovation to be translated into patient access to medicines in evolving healthcare systems.

　　4.在應(yīng)對(duì)創(chuàng)新帶來(lái)的共同挑戰(zhàn)方面開展國(guó)際合作，有助于通過(guò)聯(lián)合解決問(wèn)題、資源匯集、能力建設(shè)以及監(jiān)管工具、標(biāo)準(zhǔn)的趨同，解決這些復(fù)雜問(wèn)題。

　　International cooperation in dealing with the common challenges posed by innovation helps solve these complexities through joint problem solving, resource pooling, capacity building and the convergence of regulatory tools and standards.

(責(zé)任編輯：李碩)