1.FDA 的电子通用技术文档(eCTD)技术合规指南(eCTD Technical Conformance Guide) 2.FDA 的行业指南《药械组合产品现行良好生产规范要求》(guidance for industry, Current Good Manufacturing Practice Requirements for Combination Products) ...
欧盟在欧洲地区应用了该eCTD规范,并加入欧洲模块1使其完整。 除了继续发展和维护电子递交标准外,为了适当地从EMA和各个国家主管部门的角度实施eCTD,有许多先决条件。这些措施包括开发必要的业务流程来接收和处理电子递交(特别是eCTD);制定政策,特别是关于电子归档的政策;以及制定和实施适当的技术基础设施和系统措施。 EMA...
This guideline provides additional support for the electronic Common Technical Document (eCTD) format (Volume 2B Notice to Applicants Medicinal Products for Human Use – Presentation and Format of the Dossier). Relevant information pertaining to the medical device and/or part of a medical device shou...
For the format of the submission, see question "Can or must I submit my post-authorisation application in eCTD format". 6. When shall I submit my Type II Variation application? The MAH shall submit Type II application(s) at the latest by the recommended submission dates published on the ...
It contains tables to be filled in, statements and declarations to be signed • Quality Overall Summary (see template on the EDQM website) • Fees: • Electronic submissions encouraged (eCTD, NeeS, pdf) • Dossier in English (preferably) or French (see documents on the EDQM website)...