欧盟监管科学战略研究及对我国的启示  

Research on European Regulatory Science Strategy and Its Enlightenment to China

作　　者：李旭 谢宇 张晶 周孟 蒯丽萍 周颖玉 Li Xu;Xie Yu;Zhang Jing;Zhou Meng;Kuai Liping;Zhou Yingyu(China Pharmaceutical University,Nanjing 211198 China;Science&Technology Development Center of CPA,Beijing 100022,China)

机构地区：[1]中国药科大学,南京211198 [2]中国药学会科技开发中心,北京100022

出　　处：《中国药事》2021年第3期357-362,共6页Chinese Pharmaceutical Affairs

摘　　要：目的:探讨欧盟监管科学战略的制定过程与主要内容,归纳欧盟监管科学战略的特点,提出其对我国监管科学发展的启示性建议。方法:检索欧盟药品监管机构的政策文件以及欧盟相关学术机构的文献与资料,基于研究框架,通过内容分析提取要点。结果与结论:总体来看欧洲药品管理局(EMA)监管科学战略的重点体现在两个方面,一是注重科学、技术和证据,为成员国提供技术支持;二是围绕监管科学战略,建立监管科学实施的沟通与协调机制。在我国监管科学战略发展过程中,要明确促进药物创新研发的总体目标,注重与利益相关方的交流合作,不断更新监管工具和监管方法以适应新时代科技进步,持续改进与完善监管框架,定期开展监管科学领域的研究,推进研究成果转化等。Objective:To introduce the formulation process and main contents of the EU regulatory science strategy,summarize the characteristics of the EU regulatory science strategy,and put forward its enlightenment to the development of China’s regulatory science.Methods:The policy documents of EU drug regulatory agencies and the literature and data of relevant EU academic institutions were searched,the key points were extracted through content analysis based on the research framework.Results and Conclusion:In general,EMA regulatory science strategy focuses on two aspects:one is to focus on science,technology and evidence to provide technical support for member countries;the second is to establish a communication and coordination mechanism for the implementation of regulatory science around the strategy of regulatory science.In the development of the progress of the regulatory science strategy in China,we should define the overall goal of the promotion of the innovative drug research and development,pay attention to the exchanges and cooperations with stakeholders,constantly update regulatory tools and regulatory methods to adapt to the new era of science and technology progress,continuously improve and perfect the regulatory framework,conduct regulatory science study regularly,and promote the transformation of research results,etc.

关 键 词：监管科学 战略计划 药物创新 利益相关者合作 

分 类 号：R95[医药卫生—药学]