我国化学仿制药生产企业申请达到WHO药品预认证标准的激励因素和技术差距研究

发布时间：2018-09-18 21:23

【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。
[Abstract]:Objective: to investigate the incentive factors and technical gap for Chinese chemical imitation drug manufacturing enterprises to meet the World Health Organization (WHO) (WHO PQ) standards for drug pre-certification. Methods: a questionnaire survey was conducted to investigate the motivating factors and technical difficulties in 47 oral solid chemical imitation drug manufacturers in China. Results: most (98%) enterprises have the intention to apply for WHO PQ, to improve the quality management system. The incentive factors are mainly four aspects: 1 to implement the 2010 revised GMP and to carry out the generic drug consistency evaluation .2 to implement international standards. Enter the international market .3 to enhance corporate image and impact. 4 quality improvement investment can be recognized in domestic essential drugs bidding. There are two main technical gaps in meeting WHO PQ standards: first, implementing WHO GMP standards, focusing on quality assurance systems and risk management; second, registering documents, mainly including bioequivalence tests, Study on Information supply and Stability of active API Manufacturing Enterprises. Conclusion: the application for WHO PQ by Chinese chemically-imitated drug manufacturers is the result of multiple incentive factors. Compared with WHO PQ standards and their own level, enterprises believe that there is a technical gap to meet WHO PQ standards. Under the background of advocating the improvement of drug quality, the internationalization of drug production and supervision, the research results can be used for reference and guidance.
【作者单位】：沈阳药科大学;中国食品药品检定研究院;世界卫生组织驻华代表处;中国医药质量管理协会;
【基金】：Bill and Melinda Gates Foundation(Global Health Grant Number OPPGH5258)
【分类号】：R95

【共引文献】