FDA在2016年优先处理的事项 - 药群论坛

Janet Woodcock M.D., Director of FDA'sCenter for Drug Evaluation and Research (CDER), has published an overview onthe forthcoming 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 thisshort presentation CDER 2016Priorities don't have a direct GMP impact. So what would be the mostimportant ones for the readers of this newsletter? The overall mission does notcome as a surprise. It is to ensure "an accessible supply of safe andeffective drugs, and preventing introduction of unsafe, ineffective orcounterfeit drugs". The outlook itself starts with a review on what wasachieved in 2015, like for example the completion of the standup of an Officeof 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 burnerpriorities" for 2016, the implementation of FDA'strack and trace programshould be continued with the implementationof statutory provisions related to the drug supply chain and track and trace.At least an important project is the whish to make "significant progresson FDA-EU mutual 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 givenon the QualityMetrics initiative. FDA sees that metrics are already widely used inquality management in many manufacturing sites and they are already often usedto "alert management to impending problems". The FDA wants to collectQuality Metrics from production sites supplying APIs, medicinal products, Biotech,OTC etc. to the US to schedule inspections based on risk assessment. Now it istime to make sure metrics "represent the same measure across variousgroups". This will certainly be a pre-requisite to 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。