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| 基于世界卫生组织认证分析我国医药行业国际化的机遇与挑战 |
| Reflection on the Internationalization of Pharmaceutical Industry from the Perspective of WHO Prequalification Program: Opportunities and Challenges |
| 投稿时间：2020-09-04 修订日期：2020-12-25 |
| DOI： |
| 中文关键词: 医药行业 国际化 世界卫生组织 认证 |
| 英文关键词: pharmaceutical industry internationalization WHO prequalification |
| 基金项目: |
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| 中文摘要: |
| 目的：对我国医药行业（包括化学原料药及制剂、疫苗、体外诊断试剂）参与世界卫生组织认证（the World Health Organization Prequalification, WHO PQ）情况进行梳理和分析，为我国医药行业国际化发展提供启示和建议。方法：通过文献收集和数据查询，描述性分析了我国化学药品（原料药和制剂）、生物制品（疫苗和体外诊断试剂）WHO PQ的背景、现状和积累的相关经验，并以此讨论我国医药行业国际化进程中面临的机遇与挑战，提出应对途径。结果与结论：对于化学药品而言，中国制剂认证远落后于原料药，应克服其质量准入门槛高、自主创新能力不足等问题。疫苗和体外诊断试剂认证数量少，与企业国际化经验少、资本不集中、缺乏具有国际竞争力产品有关。建议我国医药行业充分吸收印度成功经验，重创新、重人才；发挥中国药检体制优势，由上而下提升药品检验检测能力和质量管理水平；了解WHO采购项目的需求品种，具有优势企业应主动争取WHO技术帮扶；消化本土企业认证经验，因地制宜，加快医药产品国际化进程。 |
| 英文摘要: |
| Objective: To provide insights and recommendations on the internationalization of pharmaceutical industry by reviewing and examining of the engagement of China manufactures of chemical drugs, vaccine, and in vitro diagnostics (IVD) with World Health Organization Prequalification (WHO PQ) Program. Methods: Lists of prequalified medicines and laboratories were obtained from the WHO website. The background, status and experiences of WHO PQ were collected and descripted by literature review in terms of chemical drug (including both active pharmaceutical ingredients (APIs) and finished pharmaceutical products (FPPs)), biologicals (vaccine and IVD). And then discuss the opportunities and challenges faced by China domestic manufacturers in the internationalization process. Results and Conclusion: As far as chemical drugs are concerned, their FPPs’ prequalification lags far behind APIs’, which are due to FPPs’ higher quality requirements and insufficient independent innovation ability of its manufacturer. The small number of prequalified vaccines and IVDs is related to the lack of internationalization experience, capital investment and internationally competitive products. It is suggested that China's pharmaceutical industry should fully absorb India's successful experience and attach importance to innovation and talents, take advantages of China's drug inspection system to improve the drug control ability and quality management level, seek technical assistance from WHO by learning the demand varieties of WHO procurement projects, and digest the prequalification experience of local enterprises to adjust strategies to WHO conditions, and accelerate the internationalization of pharmaceutical products. |
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