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

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。

On Internationalization of Chinese Pharmaceutical Industries Based on the WHO Prequalification Program:Opportunities and Challenges

Objective:To provide insights and recommendations for internationalization of pharmaceutical industries by reviewing and examining the engagement of Chinese manufactures of chemical drugs,vaccine,and in vitro diagnostics(IVD)in the World Health Organization Prequalification(WHO PQ)Program.Methods:Through literature collection and data query,the background,current situation and accumulated experiences of WHO PQ were analyzed and described in terms of chemical drugs(pharmaceutical ingredients and preparations),and biologicals(vaccines and IVD)in China.The opportunities and challenges faced by Chinese manufacturers in the process of internationalization were discussed and the measures were put forward.Results and Conclusion:As far as chemical drugs are concerned,the FPPs’prequalification lags far behind APIs’,which is due to FPPs’higher quality requirements and insufficient innovation abilities 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,attach importance to innovation and talents,take advantage of China's drug inspection system to improve the drug control ability and quality management and understand the variety of products required for WHO procurement projects.Enterprises with advantages should take the initiative to seek the help of WHO technology,digest the prequalification experience of local enterprises to adjust strategies to WHO conditions,and accelerate the internationalization of pharmaceutical products.