FDA在2016年优先处理的事项

julia朱玉姣

GMP News
23/12/2015

What are FDA's 2016 Priorities?

FDA在2016年优先处理的事项

Janet Woodcock M.D., Director of FDA's Centerfor Drug Evaluation and Research (CDER), has published an overview on theforthcoming priorities of the center (CDER regulates over-the-counter andprescription drugs, including biological therapeutics and generic drugs).

JANET WOODCOCK M.D.是FDA药品审评中心（CDER）的主任，他刚刚公布了中心未来优先处理事项概览（CDER管理非处方药、处方药和非处方药，包括生物治疗和仿制药）。

Most of the priorities listed in this short presentation CDER 2016 Priorities don't have a direct GMP impact. Sowhat would be the most important ones for the readers of this newsletter? Theoverall mission does not come as a surprise. It is to ensure "anaccessible supply of safe and effective drugs, and preventing introduction ofunsafe, ineffective or counterfeit drugs". The outlook itself starts witha review on what was achieved in 2015, like for example the completion of thestandup of an Office of Pharmaceutical Quality.

在此简短的CDER于2016年优先处理事项的说明中列出的大部分事项并不直接对GMP产生影响。那么对于读者来说，这份简讯中最重要的是什么呢？其给出的总体使命并没什么惊人之词，它说的是确保“药品的正常有效安全供应，防止不安全、无效或假药引入市场”。展望是从2015年完成的任务开始的，如完成了药品质量办公室的设立。

As one of the "front burner priorities" for2016, the implementation of FDA's track and trace program should be continued with theimplementation of statutory provisions related to the drug supply chain andtrack and trace. At least an important project is the whish to make"significant progress on FDA-EUmutual reliance initiative". However FDA is clearly not infavour of an MRA (Mutual Recognition Agreement) to automatically rely on EUinspections.

作为2016年“最优先事项”之一，实施FDA追溯和跟踪项目将持续实施与药品供应链有和追溯跟踪有关的法定条款。至少有一个重要项目是期望“在FDA与欧盟互认倡议上取得重大进展”。但是，FDA很显然并不赞同通过MRA（互认协议）来直接依赖于欧盟检查。

A little bit more information is given on the Quality Metrics initiative. FDA sees that metrics arealready widely used in quality management in many manufacturing sites and theyare already often used to "alert management to impending problems".The FDA wants to collect Quality Metrics from production sites supplying APIs,medicinal products, Biotech, OTC etc. to the US to schedule inspections basedon risk assessment. Now it is time to make sure metrics "represent thesame measure across various groups". This will certainly be a pre-requisiteto compare data.

在质量量度倡议方面给出的信息更多一点。FDA看到质量量度已在许多生产场所广泛应用于质量管理，通常也已经用于“警示对即将发生的问题进行管理”。FDA想要从向美国供应原料药、制剂、生物制品、OTC等的生产工厂收集质量量度信息，并依据风险评估来制订检查计划。现在是保证量度“代表各不同集团里相同的测量方式”的时候了。这肯定会是数据比较的前提。

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