| 王轩,董凌云,钱莉苹,张颖,朱文涛.我国相关法规建设对促进儿童用药研发的探究[J].中国药事,2023,(2):134-141 |
| 我国相关法规建设对促进儿童用药研发的探究 |
| The Consideration of Analysis on the Construction of Relevant Laws and Regulations to Promote the Research and Development of Pediatric Medication |
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| DOI：10.16153/j.1002-7777.2023.02.002 |
| 中文关键词: 儿童用药 药物研发 法规建设 药品注册 政策建议 |
| 英文关键词: pediatric medication research and development of medication regulations construction drug registration policy advise |
| 基金项目: |
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| 中文摘要: |
| 目的：儿童用药是当前全球临床需求面临的重要问题之一，推动儿童用药研发是监管方和工业界共同面对的问题。本文旨在进一步完善促进我国儿童用药的政策体系搭建并发挥其在药品注册体系中的作用。方法：通过总结当下国内儿童用药现状，梳理我国卫生相关部门已出台的针对性政策以及现阶段取得的成效，进一步提出我国儿童用药法规体系建设在药品研发领域的发展建议。结果与结论：我国儿童药物研发起步较晚，因药品研发成本高、周期长和利润回报率低等多重问题导致儿童用药在临床使用上存在问题。当前，在我国已出台的相关法规政策的促进下，儿童用药研发取得较好成果的同时还需加强相关积极政策的制订导向，建议相关部门结合我国特色，根据实际突显的问题及时进行法规政策体系调整优化。 |
| 英文摘要: |
| Objective: Pediatric medication is one of the important issue facing the global clinical needs, and promoting the research and development of pediatric medication is a common problem to be addressed with the regulators and the industry. This article aims to further promote the policy system of promoting pediatric medication in China and enhance its role in drug registration system. Methods: By summarizing the current domestic situation in pediatric medication, sorting out the targeted policies introduced by health related departments in China and the results achieved at the present stage, to further come up with the development suggestions of the construction of pediatric medication in regulation system in China in the fi eld of drug research and development. Results and Conclusion: Pediatric medication research and development started late in China. Due to the high cost, long cycle and low profi t return rate of drug research and development, the use in clinical of pediatric medication still have many problems. At present, under the relevant regulations and policies that have been introduced in China, while the research and development of drug use in children has made better results, it is also necessary to strengthen the guidance of relevant active policies. It is suggested that relevant departments should adjust and optimize the regulation and policy system in time according to the problems highlighted by the Chinese situation. |
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