在美国,通常通过FDA的Investigational New Drug (IND)程序提交。在欧洲,通常通过EMA的Clinical Trial Application (CTA)程序提交。 5. 申请评估和审查: 监管机构将评估您的申请文件,确保其合规性和安全性。 监管机构可能会提出问题或需要额外的信息,您需要积极合作并提供所需的信息。 6. 接
3. 准备临床试验申请(CTA): 根据监管要求,准备全面的临床试验申请(Clinical Trial Application, CTA)。这包括试验协议、受试者知情同意书、数据收集和分析计划、质量控制计划、药物/医疗器械信息等。 4. 申请提交: 按照FDA或EMA的指南和要求,提交临床试验申请。确保提供所有必需的文件和信息,并遵循指定的电子提交要求。
在提交ATMP申请的过程中,赞助商遵循与其他疗法产品相同的程序:提交和接收临床试验申请 (CTA,clinical trial applications) 的批准、进行临床试验、准备和提交上市许可申请 (MAA,marketing authorization application) 以供批准、请求科学建议,以及回答监管机构问题...
在欧洲,提交试验计划前需要提交临床试验申请(Clinical Trial Application,CTA)。 5. 遵循规定的格式和要求: 根据监管机构的要求,以规定的格式提交所有必需的文件。 注意文档的准确性、清晰度和完整性。 6. 提前沟通: 提前与监管机构进行有效的沟通,尤其是在试验设计和文件准备的早期阶段。 遇到任何不确定的问题,可以...
在提交ATMP申请的过程中,赞助商遵循与其他疗法产品相同的程序:提交和接收临床试验申请(CTA,clinical trial applications)的批准、进行临床试验、准备和提交上市许可申请(MAA,marketing authorization application)以供批准、请求科学建议,以及回答监管机构问题。负责监督ATMP的EMA机构是先进疗法委员会(CAT,Committee for Advanced...
The feasibility of starting a new clinical trial or including new trial participants in an ongoing trial should be critically assessed by sponsors. 申办者应严格评估开始新临床试验或在正在进行的试验中招募新的受试者的可行性。 Changes in ongoing trials ...
New therapeutic agents targeting the production of proangiogenic signalling pathways in the in retina have been tested in experiments, including local mTOR inhibitors application. We initiated a randomized clinical trial to evaluate the role of systemic mTOR inhibition after SPK in the course of...
The IMPD should include the most up-to-date information relevant to the clinical trial available at time of submission of the clinical trial application. 1.5. General considerations For drug substances or IMPs to be used in clinical trials as described in chapters 2 to 8, reference to either ...
Ph. Eur. Dosage Form Monographs: Liquid Preparations for Cutaneous Application; Powders for Cutaneous Application; Semi-Solid Preparations for Cutaneous Application; Ear Preparations; Eye Preparations; Pressurised Pharmaceutical Preparations. 欧洲药典,剂型通则:皮肤用液体制剂、 皮肤用粉末制剂、 皮肤用半固体制...
Looking to outsource Clinical Trial Applications? BlueReg offers a variety of services that bring together our global clinical and regulatory expertise to simplify your journey to market. The clinical development process can be complex and can cost your organisation significant time and money. Associated...