The U.S. Food and Drug Administration (FDA) published a revised version of its Quality Metrics Guidance (Submission of Quality Metrics Data). The goal of a final guidance will be the collection of quality metrics data from pharmaceutical companies to foster the agencys aim of a risk based inspection planning. A first draft guidance was published in 2015, leading to a lot of responses from industry.

FDA近期公布了质量量度指南的二次修订版 - 质量量度数据的提交。本指南的目的是要从药厂采集质量量度数据,以达成FDA戏能能采取基于风险的检查计划的目标。指南的第一版草案已在2015年公布,也引发了众多行业的回响。

Whats new in the revised draft? 

此次草案的修订版有哪些新内容?

• The program will begin with a voluntary phase that will run into 2018.   After this rather short period, the program should become mandatory.

  从现在起到2018年的期间内,质量量度计划会先以自愿提交的方式进行,在这段期间之后,正式成为强制性的措施。

• The scope will be narrowed with three different primary metrics instead of   four, allowing more flexibility and a reduction in reporting burden: lot   acceptance rate (LAR), a product quality complaint rate (PQCR) and an   invalidated out-of-specification rate (IOOSR) plus three optional metrics.

  质量量度数据的范围将缩小到三类主要的数据,而不是四类,以减少工作量并提供更大的弹性,包括批生产合格率,产品投诉率,和未经确定的OOS发生率,加上三个可选的质量量度数据。

• Both product reports and site reports would be possible

  可以提交整厂或某产品的质量量度数据报告

• Modifications to the quality metrics data definitions with clarifying examples

  修改了质量量度数据的定义,并提供了参考例子以便澄清。

In its Federal Register Notice Docket No. FDA-2015-D-2537, Submission of Quality Metrics Data; Draft Guidance for Industry; Availability; Request for Comments,  the FDA states that it recognizes that a voluntary phase of the program would give participants an opportunity to demonstrate transparency and a willingness to proactively engage with the Agency in pursuit of the goals described in the revised draft guidance.

在这次的修订版,FDA表示他们已认识到,有了自愿提交的缓冲期,能让药厂有机会证实其积极参与质量量度计划的意愿,和其质量量度数据的透明度,以达成指南修订版中提到的目标。

Additionally the FDA plans to release a new version of the Technical Conformance Guide it issued last June to support the revised draft guidance.

此外,FDA也计划公布一份新版的技术一致性指南 (去年6月公布了初版),来支持本指南修订版。