安徽省中药配方颗粒上市前备案申报资料常见问题分析及建议

On Common Problems of Pre-listing Filing and Application Materials of Traditional Chinese Medicine Formula Granules in Anhui Province

目的:研究安徽省中药配方颗粒上市前备案资料审查中发现的常见问题,为中药配方颗粒生产企业提升备案资料质量和加强生产质量管理提供参考。方法:以中药配方颗粒生产企业通过国家药品监督管理局药品业务应用系统提交的上市前备案资料为研究对象,采用汇总归纳的方法对备案资料中发现的常见问题进行分析总结。结果:中药配方颗粒生产企业的上市前备案资料在完整性、生产资质、物料的执行标准、生产工艺、检验、药材基原、药用部位等方面还存在不足和问题。结论:生产企业应深入学习中药配方颗粒监管法规,准确把握上市前备案资料要求,切实履行中药配方颗粒生产和质量保证的主体责任,确保备案资料的真实、完整和可追溯。

Objective:To study the common problems found during the inspection of the pre-listing filing materials of traditional Chinese medicine formula granules in Anhui Province,so as to provide references for the manufacturing enterprises of traditional Chinese medicine formula granules,to improve the quality of the filing materials and strengthen the production quality management.Methods:Taking the pre-listing filing materials submitted by Chinese medicine formula granules manufacturing enterprises through the pharmaceutical business application system of National Medical Products Administration as the research object,the common problems found in the filing materials were analyzed and summarized by the method of summarization.Results:Some shortcomings and problems were found in the pre-listing filing materials of Chinese medicine granule manufacturing enterprises in terms of completeness,production qualification,implementation standards of materials,production technology,inspection,medicinal materials origin and medicinal parts.Conclusion:Manufacturing enterprises should thoroughly study the regulatory laws and regulations of traditional Chinese medicine formula granules,accurately grasp the requirements of filing materials before listing,earnestly fulfill the main responsibility of production and quality assurance of traditional Chinese medicine formula granules,and ensure the authenticity,completeness and traceability of filing materials.