GMP News7 G8 | B. U' `3 j- Z
01/10/2014
Saudi Food and Drug Authority publishes Drug Master File Guidance
沙特FDA公布其DMF指南
This year in August, the regulatory authority of Saudi Arabia published a guideline entitled "Drug Master File (DMF): Guidance for Submission". The document describes the formal prerequisites to be fulfilled to ensure the successful submission of a DMF. The following elements have to be part of a DMF: 今年8月，沙特阿拉伯法规部门公布了一份题为“DMF申报指南”的文件。文件中描述了为保证成功提交DMF所需满足的正式要求。以下要素是DMF必须包括的内容：
- Cover letter - This letter shall include all technical-formal information like for example the name of the API, trade name, name and address of both the manufacturer and the DMF holder, registration or reference number.
- 封面函：该函应包括所有正式的技术资料，例如原料药名称、商品名、生产商和DMF持有人的名称和地址、登记号或索引号。
- Letter of access: authorisation to review and reference the DMF.; F x3 |5 M+ \1 q5 w
The same information as in the cover letter should also be indicated here. If the API is manufactured at different manufacturing sites, all sites have to be listed. - 授权信：授权审阅和引用DMF。这里要包括与封面函中相同的信息。如果原料药在不同的场所生产，则需要列出所有的生产场所。
- Formal requirements for the DMF: the DMF must be written either in English or Arabic. Only one electronic-based copy - a CD - should be submitted. If the data volume exceeds 750 MB, a DVD should be used.
- 正式DMF要求：DMF必须用英文或阿拉伯文书写。只需要提交一份电子版（CD）。如果数据量大于750MB，则应使用DVD。
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In the context of this DMF Guideline, there is another important document entitled "Guidance for Submission" published by the SFDA in March 2014 in the updated version 4.0. The document contains further technical details about the storage media to be used for all submissions made to the SFDA, e.g. security requirements, password and virus protection, etc. These requirements should also be considered for the submission of Drug Master Files." K/ A" A' Z0 N. }
在本DMF指南中，有另一个重要的文件题为“申报指南”，由SFDA在2014年3月公布，版本更新为4.0。指南文件中包括进一步详细指南说明提交给SFDA的保存介质，例如，安保要求、密码和病毒保护等。在提交DMF时也要考虑这些要求。
& G# [- i2 y1 G% K* ]Further regulations and guidelines of the Saudi Authority relevant for authorisation can be found on thewebsite of the SFDA. 在SFDA官网上可以找到沙特药监与进一步法规和指南规定