化学仿制药特殊滴眼剂研究技术指导原则2026

（一）处方 2（二）生产工艺 2（三）质量研究 2（四）稳定性研究 3 3 3 5），提出混悬型滴眼剂和乳状型滴眼剂等特殊滴眼剂仿制药研展进一步的临床研究。若药学研究和/或非临床研究结果提（一）处方（二）生产工艺特殊滴眼剂的生产工艺可能影响药物的药代动力学行（三）质量研究制药与参比制剂质量一致。原则上应提供至少3批参比制剂和粒度分布、黏度、表面张力、沉降体积比、再混悬/再分散性、可溶性的药物量、含量均匀度、Zeta电位、体外释放（四）稳定性研究特殊滴眼剂的眼组织或药效作用部位分布可能受到颗仿制药与参比制剂处方和工艺的差异可能导致药物药代动药学对比研究不足以充分反映仿制药与参比制剂体内行为要的眼组织分布和/或非临床药代动力学对比研究，重点关注仿制药与参比制剂在眼组织分布的一致性。临床对比研究的程度应基于仿制产品的制剂复杂程度、药学和非临床对比研究等情况，开展必要的临床对比研究，临床对比研究评估仿制药与参比制剂的一致性，对比研究显示与参比制剂基本一致、非临床研究开发和应用科学合理的经过验证的局部药代动力学研究方研究人群、给药途径和剂量、有效性终点、idelineQ8:Pharmaceuticaldevelopment[EB/OL].August,2009./sites/default/files/Q8%28R2%29%20Guideline.pdf.[3]UnitedStatesPharmacopeialConvention.USP-NF2026,<771>OphthalmicProduct[4]UnitedStatesPharmacopeialConvention.USP-NF2026,<1207>PackageIntegrityEvaluation-SterileProducts[5]EuropeanPharmacopoeia.EP12.3,<1163>EyePreparations[S].2026.[6]国家药品监督管理局药品审评中心.《关于发布<化学药品注射剂仿制药质量和疗效一致性评价技术要求>等3n/main/news/viewInfoCommon/d9c6f118b773f54e8feba3519bf78a11.mmon/8a1c258dea8798a6c6d6c1e0a14d1c1f./xxgk/ggtg/ypggtg/ypqtggtg/20140513120001448.ht[9]FDA.Andasubmissions-refuse-to-receivestandardsguidanceforindustry[EB/OL].October2017.https://www.f/regulatory-information/search-fda-guidance-documents/anda-submissions-refuse-receive-standards-questions-and-answers-guidance-industry.[10]FDA.Qualityconsiderationsfortopicalophthalmicdrugproductsguidanceforindustry[EB/OL].December2023./regulatory-information/sidance-documents/quality-considerations-topical-ophthalmic-drug-products.[11]FDA.Considerationsforwaiverdjustersingenericdrugproductsintendedforparenteralhthalmic,oroticuse[EB/OL].April2022.https://www.fda.gov/drugs/news-events-human-drugs/decoding-guidance-considerations-waiver-requests-ph-adjusters-generic-drug-products-intended.ingofdrugsubstancesandproductsquestionsandanswers [EB/OL].May2014./regulatory-information/search-fda-guidance-documents/andas-stability-testing-drug-substances-and-products-questions-and-[13]EMA.Qrdrecommendationsontheexpressionof strengthinthenameofcentrallyauthorisedhumanmedicinalproducts（asstatedinsechttps://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/quality-review-documents-recommendations-expression-strength-name-centrally-authorised-human-medicinal-products_en.pdf.applicationformarketingauthorisationofamedicinalproduct[EB/OL].June2007.https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-excipients-dossier-application-marketing-authorisation-medicinal-product-revision-2_en.pdf.eservativesinophthalmicpreparationsforhumanuse[EB/OL].December2009.https://www.ema.europa.eu/en/documents/public-statement/emea-public-statement-antimicrobial-preservatives-ophthalmic-preparations-human-use_en.pdf.oftopicalproducts[EB/OL].October2018.https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-quality-and-equivalence-topical-products_en.pdf.[17]EMA.Guidelineonthesterilisationonalproduct,activesubstance,excipientandprimarycontainer[EB/OL].March2019.https://www.ema.europa.eu/en/documents/sci