局部作用阴道制剂仿制药评价要点

Discussion on the Main Review and Evaluation Points of the Consistency of Quality and Efficacy of Topical Vaginal Preparations

目的局部作用阴道制剂是一类经阴道途径给药,发挥局部作用的制剂,本文探讨了该类制剂仿制药的评价要点,为国内阴道制剂仿制药的研发与审评提供借鉴。方法通过文献调研,收集美国、欧盟、日本及中国的阴道制剂的批准上市情况及药典收载情况,探讨美国食品药品监督管理局(FDA)及欧洲药品管理局(EMA)关于局部作用阴道制剂仿制药的审评要求,分析了该类仿制药与原研药进行质量与疗效一致性的技术要点。结果与结论该类仿制药的药学研究需关注处方工艺的合理性、关键质量属性研究的合理性、批间一致性及与原研产品的一致性。FDA和EMA通常以临床试验研究来评价该类仿制药与原研制剂的疗效和安全的一致性,一般需要大量受试者。

Topical vaginal preparations are administered via vaginal channels to play a local role. This paper discussed review points of vaginal generic drugs in order to provide references for research and review of this drugs in china. METHODS By literature research, the paper collected the approval information and the pharmacopoeia record information of the USA, the EU, the JP and the China, discussed the review points of vaginal generic drugs in combination with the review requests of FDA and EMA, and analyzed the technical points of the quality and efficacy of vaginal generic drugs. RESULTS AND CONCLUSIONS The pharmacy researches on vaginal generic drugs should focus on the rationality of prescription, process and critical quality attribute researches, concerned the consistence of inter -batch and reference listed drug. FDA and EMA usually review the equivalence of efficacy and safety with clinical trials which often need a great deal of volunteers.