论文总字数：19849字

摘 要

目的：研究我国当下仿制药产业的发展困境并分析原因，以促进我国仿制药产业更加蓬勃健康的发展，逐步走向国际化道路。方法：本文通过数据调研、文献分析的方法来研究我国仿制药发展现存的问题，结合实践经验总结，借鉴美国先进的仿制药管理经验，结合我国国情，提出有利于我国仿制药产业发展的政策性建议。结果：本文从市场、企业、政府三个角度切入，通过大量图表数据和文献资料，总结出制约我国仿制药产业发展的因素包括：仿制药水平低、开发投入少、市场集中度低、一致性评价政策现存问题等。结论：我国是仿制药产业大国，但还不是仿制药强国，要向国际化进程推进，我们必须首先保证仿制药的质量和疗效，其次政府应制定弹性政策，加速仿制药的审评审批，鼓励企业的研发创新。企业积极应对市场需求及政策变化，结合自身发展，弹性选择产品投入。

关键词：仿制药；发展困境；政策建议

China's Generic Pharmaceutical Industry Development Dilemma and Policy Recommendations

Abstract

Objective: To study the development dilemma of China's current generic drug industry and analyze the reasons, so as to promote the more vigorous and healthy development of China's generic drug industry, and gradually move towards internationalization. Method: This paper studies the existing problems in the development of China's generic drugs through data surveys and literature analysis, combined with practical experience summaries, drawing on advanced US generic drug management experience, and combining with China's national conditions, it proposes policies that are beneficial to the development of China's generic drug industry Suggest. Results: This article cuts in from three perspectives: market, enterprise, and government. Through a large amount of chart data and literature, the factors restricting the development of China's generic drug industry include: low level of generic drugs, low development investment, low market concentration, and consistency Existing problems in evaluating policies, etc. Conclusion: China is a big country in the generic drug industry, but it is not a strong generic drug. To advance to the internationalization process, we must first ensure the quality and efficacy of generic drugs. Second, the government should formulate flexible policies to accelerate the review and approval of generic drugs Enterprise R amp; D and innovation. Enterprises actively respond to market demand and policy changes, and combine their own development to flexibly choose product inputs.

Keywords: Generic Drugs, Development Dilemma, Policy Recommendations

目录

摘要..................................................................................I

Abstract..............................................................................II

第一章 绪论............................................................................1

1.1研究背景与意义................................................................1

1.2研究方法......................................................................1

1.3研究内容.......................................................................1

1.4研究现状.......................................................................1

第二章 理论基础........................................................................3

2.1仿制药的定义及相关概念.........................................................3

2.1.1仿制药定义...............................................................3

2.1.2仿制药的发展历程.........................................................3

2.2仿制药的研发生产...............................................................3

2.3我国仿制药的注册申请流程.......................................................3

2.3.1前期的市场品种调研.......................................................3

2.3.2中期反复进行质量和稳定性研究、BE实验.....................................3

2.3.3后期撰写注册申报资料.....................................................4

2.3.4 递交申请.................................................................4

第三章 我国仿制药产业的发展.............................................................5

3.1发展现状与问题.................................................................5

3.1.1行业现状.................................................................5

3.1.2我国仿制药产业目前存在的问题.............................................6

3.2我国制药企业的发展现状.........................................................7

3.2.1市场竞争格局与问题.......................................................7

3.2.2仿制药市场的贸易竞争壁垒.................................................8

3.3我国仿制药一致性评价现状分析...................................................8

第四章 美国仿制药管理分析与借鉴........................................................10

4.1美国仿制药管理发展进程........................................................10

4.1.1立法历程................................................................10

4.1.2“桔皮书”的出台........................................................10

4.1.3简化新药申请声明........................................................10

4.2借鉴美国仿制药管理政策........................................................10

4.2.1完善数据库查询系统......................................................10

4.2.2加速仿制药审批效率......................................................11

4.2.3加大监督力度...........................................................11

第五章 我国仿制药产业发展前景与建议..................................................12

5.1仿制药行业发展趋势分析........................................................12

5.1.1市场.....................................................................12

5.1.2企业...................................................................12

5.2不同企业的应对策略............................................................12

5.2.1大型企业................................................................12

5.2.2中小型企业..............................................................12

5.3依据本国国情制定相应政策......................................................12

5.3.1抓好仿制药一致性评价....................................................12

5.3.2加强日常监管,保障药品质量...............................................13

5.3.3加快审评进度,提升审批效率...............................................13

5.3.4支持各型企业健康发展....................................................13

5.3.5创建公平竞争环境........................................................13

5.3.6政府给予引导和支持......................................................13

5.3.7重视国际化进程.........................................................13

第六章 结论与总结...................................................................14

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