摘要
目的:调查研究我国化学仿制药品生产企业申请达到世界卫生组织药品预认证(WHO PQ)标准的激励因素和技术差距。方法:以国内47家口服固体化学仿制药品生产企业为对象,采用问卷调查法,研究达到WHO PQ标准的激励因素和技术困难。结果:绝大部分(98%)企业有意愿申请WHO PQ,提升质量管理体系,激励因素主要有4个方面:1执行我国2010年修订的GMP和开展仿制药一致性评价。2执行国际标准,进军国际市场。3提升企业形象和影响力。4质量提升的投入能够在国内基本药物招标中获得认可。达到WHO PQ标准的技术差距主要有两方面:一是执行WHO GMP标准,集中在质量保证体系和风险管理;二是注册文档,主要包括生物等效性试验,活性原料药生产企业的信息提供和稳定性研究。结论:我国化学仿制药品生产企业有意申请WHO PQ是多种激励因素综合作用的结果。对照WHO PQ标准和自身水平,企业认为达到WHO PQ标准存在技术差距。在倡导药品质量提升、药品生产和监管国际化的背景下,该研究结果对各与参方有借鉴和指导作用。
Objective： To conduct investigation on incentives and technical gaps faced by Chinese manufacturers producing chemical generic medicines. Methods： A total of 47 domestic manufacturers producing chemical generic medicines in the form of oral solid dosage forms were selected. Questionnaire was designed and used to collect information among those selected manufacturers. Results： The investigation showed that a majority of firms（ 98%） expressed willingness to participate in WHO PQ program and improve drug quality standards. Four types of incentives were identified in terms of benefits felt by firms： implementation of updated Chinese GMP standards（ year 2010 version） and re-evaluation of generic medicines on market,implementation of international standardsand joining international trade,raising firms＇ reputation and image domestically,and rewarding and recognizing in domestic essential medicines bidding system. There were two types of technical gaps faced by firms： one was the implementation of WHO GMP standards,with gaps falling in quality management system and risk management; another was the preparation of regulatory dossier according to international standards,with gaps in bioequivalence study,availability of information from APIs suppliers and stability study. Conclusion： The willingness of Chinese firms to achieve the standards of WHO PQ was driven by a combination of incentives. Technical gaps were felt by firms based on their understanding on WHO PQ＇s standards and their own status. The outcome of the study could be beneficial to those stakeholders involved in assisting Chinese firms to move toward WHO PQ standards,such as WHO,domestic governmental agencies responsible for industry development and drug regulation,and drug related societies or associations.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2015年第7期725-729,共5页
Chinese Journal of New Drugs
基金
Bill and Melinda Gates Foundation(Global Health Grant Number OPPGH5258)
关键词
化学仿制药
药品生产企业
世界卫生组织药品预认证
药品生产管理规范
注册文档
激励
因素
技术差距
chemical generic medicines
medicines manufacturers
WHO medicines prequalification（PQ）
good manufacturing practices（GMP）
regulatory dossier
incentives
technical gaps
