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导航正在发展的欧亚经济联盟的制药领域:简化药物注册以获得市场准入

C P Keerthana¹, Sanjay Sharma²

¹Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management, SVKM's, NMIMS, Deemed to be University, Vile Parle West, Mumbai, Maharashtra, 400056, India.

Therapeutic innovation & regulatory science

|April 19, 2025

概括

欧亚经济联盟 (EAEU) 协调了市场准入的制药法规. 本综述详细介绍了营销许可,档案要求以及在欧亚经济联盟统一市场中的机遇.

科学领域:

药品监管事务药品监管事务
国际市场整合国际市场整合.
欧亚经济联盟 (EAEU) 政策

背景情况:

欧亚经济联盟 (EAEU) 旨在促进俄罗斯,哈萨克斯坦,白俄罗斯,亚美尼亚和吉尔吉斯斯坦的经济一体化.
建立了一个共同的制药市场,需要了解市场准入和患者安全的协调法规.
关于欧亚经济联盟不断变化的制药监管格局的文献有限,过渡期将在2025年结束.

研究的目的:

提供对欧亚经济联盟内的药品营销许可程序的见解.
详细说明档案要求,并确定制药公司的市场机会.
分析监管途径及其对进入市场的影响.

主要方法:

对监管途径的描述性分析.
审查欧亚联盟规则和来自相关网站的官方文件.
检查营销许可程序,包括去中心化和相互承认的途径.

主要成果:

欧亚经济联盟已经实施了两个主要的营销许可途径:去中心化和相互承认,反映了欧盟的模式.
预计的市场量表明,欧亚经济联盟内的制药行业正在大幅增长.
统一的监管框架虽然已协调,但仍处于全面实施的早期阶段.

结论:

对于那些寻求市场准入和患者安全的制药公司来说,了解欧亚经济联盟协调的监管框架至关重要.
由于其统一的方法和预计的部门增长,欧亚经济联盟提供了重要的市场机会.
欧亚经济联盟法规的持续发展和实施需要利益相关方不断监督.

关键词:

分散的程序是去中心化的程序.欧亚经济联盟监管框架欧亚经济联盟监管框架经济一体化经济一体化市场增长潜力市场增长潜力相互认可程序相互认可程序监管协调监管协调监管协调监管协调监管协调

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