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FDA Tackles Broken Generic Drug Application Process

机译：FDA解决破药申请

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The spirit of this guidance is to speed access to generic medicines. Today nearly 84 percent of all prescriptions filled in the U.S. are generic. The generic industry's trade group, the Generic Pharmaceutical Association (GPhA), has released figures that show the impact of generic drugs: over the last 10 years, generic drugs have saved consumers in excess of 1.2 trillion dollars. At the same time, the FDA has been making steady progress in narrowing the gap between brand drugs and generic drugs in terms of quality and efficacy. To that end, in January 2014, the FDA published in the Federal Register that it is seeking input from key stakeholders on how to improve the Abbreviated New Drug Application (ANDA) submission process. The agency has cited poor and incomplete ANDA submissions as a significant impediment to generic drug approvals. Specifically, the FDA is interested in hearing about any difficulties sponsors are having developing and preparing their ANDA submissions that the agency could help address, by providing more or better information to industry.
机译：本指南的精神是加快获取仿制药的机会。如今，在美国填写的所有处方中，将近84％是非专利药。仿制药行业贸易组织通用制药协会（GPhA）发布的数据显示了仿制药的影响：在过去10年中，仿制药为消费者节省了超过1.2万亿美元。同时，FDA在缩小品牌药物和仿制药之间在质量和功效方面的差距方面一直取得稳步进展。为此，FDA在2014年1月的《联邦公报》中表示，它正在寻求主要利益相关者的意见，以改进如何简化“新药申请”（ANDA）的提交流程。该机构指出，ANDA提交的文件不全和不完整是仿制药批准的重大障碍。特别是，FDA有兴趣了解申办者在开发和准备其ANDA呈文时可能遇到的任何困难，FDA可以通过向行业提供更多或更好的信息来帮助解决这些困难。

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