【转帖】FDA专员指出DMF经常出现的缺陷

wei616

2008/05/24

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FDA专员指出DMF经常出现的缺陷
Drug master file review issues at the Office of Generic Drugs
Abstract:

The Office of Generic Drugs (OGD) in the US Food and Drug Adminstration's (FDA) Center for Drug Evaluation and Research (CDER) has recently been receiving unprecedented numbers of abbreviated new drug applications (ANDAs); currently, more than 700 per year. Each ANDA is supported by drug master files (DMFs), which are separate proprietary documents describing the chemistry, manufacture and associated controls for the active pharmaceutical ingredients (APIs). Usually, the firm submitting the ANDA purchases the API from a fine chemicals producer who has filed a DMF with the FDA. A Letter of Authorisation (LOA) from the DMF holder allows the FDA staff to review the DMF in conjunction with review of the ANDA. An adequate DMF is one requirement for approval of an ANDA. To date, over 18,000 DMFs have been submitted to the FDA. Very few of these are found to be adequate in an initial review and, consequently, approvals of ANDAs are delayed as additional information and data are needed from the DMF holder to ensure consistent production of high-quality APIs. Illustrative examples of typical DMF deficiencies are presented in this paper and suggestions for improved DMF submissions are given.
摘要：美国FDA药品审评和研究中心（CDER）的仿制药办公室（OGD），近年来收到大量的简化新药申请（ANDAs），目前每年大约可达700个。每个申请都包含有说明API的化学、生产和相关控制的DMF文件。通常，提交ANDA的企业都从持有DMF的精细化工生产商处购买API。FDA官员凭借DMF持有者的授权书在审核ANDA申请时来审核DMF。完整的DMF是批准简化新药申请的一项基本要求。至今，已有18000份DMF递送到FDA。但在初步的DMF审核中几乎没有一份是完整合格的，这样，ANDA的批准程序因此而延迟。本文将对DMF中的典型缺陷做以详细阐述并对如何提交DMF给出建议。