1 THE ASEAN COMMON TECHNICAL DOSSIER (ACTD) FOR THE REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ORGANIZATION OF THE DOSSIER PREAMBLE This ASEAN Common Technical Dossier (ACTD) is a guideline of the agreed upon common format for the preparation of a well-structured Common Technical Dossier (CTD)...
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The ASEAN Common Technical Dossier (ACTD) was created with the aim to serve as a harmonized guideline for pharmaceutical product registrations in the ASEAN countries. The use of a common format is intended to simplify the registration process and reduce the time and resources needed to put togeth...
In Malaysia, the Philippines, and Thailand, the registration requirement is satisfied by the submission of the ASEAN common technical dossier (ACTD). In other member states, they necessitate the submission based on the requirements particular to their region. This study ...
东南亚通用提交档案模板 (CSDT; Common Submission Dossier Template) 是打算进入东南亚市场(ASEAN ; Association of Southeast Asian Nations) 的医疗器械制造商的通用模板。 这份文件与申请表一起提交给监管机构(Regulatory Authorities)的设备信息应以ASEANCSDT 格式呈现。
ASEAN CSDT在东南亚医疗器械指令 (AMDD; ASEAN Medical Device Directive) 的附件 4 中建议了ASEAN CSDT 格式,该指令由东南亚地区的十 个国家:菲律宾、马来西亚、新加坡、泰国、文莱、越南、缅甸、老挝、柬埔寨、东帝汶签署。 东南亚通用提交档案模板 (CSDT; Common Submission Dossier Template) 是打算进入东南亚市场(ASE...
registration submission for general medical devices using the ASEAN Common Submission Dossier Template (CSDT). In particular, this document serves to clarify the information to be included in each section of the CSDT and the format that this information is to be submitted in. 1.2. Background...
Methods: Collection of the following dossier format of USFDA (United States Food and Drug Administration), WHO (World Health Organization) and ASEAN (Association of South East Asian Nation) Identifying the critical and major differences among those three dossiers related to technical document. ...