推进药品监管科学，是当今世界药品监管机构实现药品监管现代化的重大战略选择。在推进药品监管科学发展中，美国和欧盟分别制定了药品监管科学战略，从全局和战略上规划药品监管科学发展的目标、重点和方向等。2010年10月美国健康和人类服务部（HHS）、美国食品药品管理局（FDA）联合发布《推进公共健康的监管科学：FDA监管科学行动计划框架》；2011年8月FDA发布《推进监管科学：战略规划》；2013年7月FDA发布《推进药品监管科学的战略及实施方案》。2020年3月，欧洲药品监督管理局（EMA）发布《监管科学2025：战略思考》。现选取部分精彩论述，供参考：

一、2010年10月HHS、FDA《推进公共健康的监管科学：FDA监管科学行动计划框架》

　　1.监管科学是指开发评估FDA监管产品的安全性、有效性、质量和性能的新工具、新标准和新方法的科学。

　　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.没有一个发现—没有神奇的子弹—能解决我们独特的现代科学监管挑战。但有一点是明确的：如果我们要解决我们今天面临的最紧迫的公共健康问题，我们需要新的方法、新的合作和新的方式，以利用21世纪的技术。我们现在就需要它们。

　　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.监管科学的进步将有助于提高审评审批效率，帮助更快地向患者提供安全的新产品，并加强监测产品使用和提高性能的能力，从而提高患者的治疗效果。

　　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.如果没有监管科学的进步，有希望的医疗方法可能就会仅仅因为我们缺乏认识其潜力的工具而在研发过程中被抛弃，或者过时的评估方法可能不必要地推迟其批准。相反，无数的金钱和时间可能被浪费在评估一种之后被证明不安全或无效的新的疗法上。

　　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may be discarded during the developmental process simply because we lack the tools to recognize their potential, or outdated evaluation methods may unnecessarily delay their approval.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.监管科学的进展不仅可以保证更好的质量，还可以降低开发和生产成本。

　　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《推进监管科学：战略规划》

　　1.FDA的决策制定必须基于现有最佳科学数据，并使用现有的最佳工具和最佳方法，以确保产品符合消费者的最高质量标准，同时还要促进和推动其所监管产品的创新。

　　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.在过去的几年里，创新科学的迅速发展为新药的发现、生产和评估以及食品安全和质量的提高提供了新的技术；FDA必须跟上并利用这些新的科学进展，以完成其保护和促进国民健康的使命。

　　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的科学家必须在一个培养创造性思维、促进科学多学科互动与协作、提供学习机会、确保科学卓越性和完美性、提供最先进的实验室和计算机技术以供使用的环境中工作。

　　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监管科学战略规划确定了关键优先领域和活动，在这些领域FDA有必要采取新的或强化的措施来参与监管科学研究，这对保持其使命的持续成功至关重要。

　　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.这项监管科学规划的成功实施，包括不同利益相关者的参与，将使FDA在完成今天监管使命的同时也为迎接明天的新挑战做好了准备。

　　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《推进药品监管科学的战略及实施方案》

　　1.药品监管科学的作用是开发必要的知识、方法、标准和工具，以提高监管决策的确定性、一致性，促进基础发现转化为切实可用的药品。

　　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通过使用科学标准来评估药品在整个生命周期中的安全性、有效性和质量，从而促进公众健康。

　　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将推进监管科学，以加快创新，改进监管决策，并将产品提供给需要的人。21世纪的监管科学将成为FDA与不同合作伙伴协作，保护和促进我们国家和全球社会健康的推动力。

　　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《监管科学2025：战略思考》

　　1.监管科学是指应用于药品质量、安全性和疗效评估的一系列科学学科，并在药品的整个生命周期内为管理决策提供信息。它包括基础和应用生物医学以及社会科学，旨在开发监管标准和工具。

　　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，创新步伐急剧加速，越来越多的药物通过整合不同技术而提供医疗解决方案，监管机构需要做好准备，以支持日益复杂的药物研发，促进和保护人类和动物健康。

　　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.为强化其保护人类健康的使命，EMA必须助力推动监管科学和创新转化为不断发展的医疗体系中患者对药物的可及性。

　　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.在应对创新带来的共同挑战方面开展国际合作，有助于通过联合解决问题、资源汇集、能力建设以及监管工具、标准的趋同，解决这些复杂问题。

　　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.

(责任编辑：李硕)