20160107 ECA新闻：MHRA药物警戒检查指标报告公布

20160107 ECA新闻：MHRA药物警戒检查指标报告公布  

GMP News
07/01/2016

MHRA Pharmacovigilance Inspection Metrics Report Published

MHRA药物警戒检查指标报告公布

The MHRA (Medicines & Healthcare products Regulatory Agency) GPvP (Good pharmacovigilance practice) inspectorate recently published their latest inspection metrics report.

MHRA（英国药监）GPVP（优良药物警戒规范）检查组最近公布了其近期检查指标报告。

During the period 01 April 2014 to 31 March 2015, the MHRA conducted a total of 48 pharmacovigilance inspections. Approximately 29% of these inspections were of marketing authorisation holders (MAH) that had not previously undergone a MHRA pharmacovigilance inspection. The largest proportion of inspections (21 inspections) was performed as routine re-inspections (i.e. of MAHs who had previously undergone a pharmacovigilance inspection).

在2014年4月1日至2015年3月31日期间，MHRA共执行了48次药物警戒检查，其中约有29%是针对上市许可持有人（MAH），这些持有人之前并没有接受过MHRA的药物警戒检查。最大的检查部分（21次检查）是常规再检查（即之前已接受过药物警戒检查的MAH）。

A total of 27 Critical, 169 Major and 155 Minor findings were identified during this period. The number of Critical findings identified during this reporting period had increased from the previous period (19 Critical findings) and were found during 17 of the 48 inspections that were performed.

在此期间总共发现27个关键缺陷，169个重大缺陷，155个轻微缺陷。相比于之前同期（19个关键缺陷）发现的48次检查中17个，在此报告期中关键缺陷数量增加了

The majority of Critical findings were reported in relation to the maintenance of reference safety information, representing 29% of all Critical findings identified. Critical findings associated with reference safety information were (again) characterised by failures and significant delays to submit safety variations to update the safety sections of SPCs (summaries of product characteristics) and PILs (patient information leaflets).

关键缺陷主要是对引用安全信息的维护，占发现的关键缺陷的29%。主要是（还是一样）未能或重大延误提交安全变更来更新SPC（药品特性总结）和PIL（患者信息说明书）的安全部分。

In this reporting period, Critical deficiencies associated with signal management represented the next largest proportion of findings identified (26% of all Critical findings). A safety signal is information on a new or known adverse event that is potentially caused by a medicine and that warrants further investigation. These signals can be generated from several sources such as spontaneous reports, clinical studies and scientific publications. Seven critical findings were reported and these were associated with:

在此报告期间，与信号管理相关的关键缺陷排在第二位（26%）。安全信号是新的或已知不良反应事件的信息，可能是由药品引起，需要进一步调查。这些讯号可能是从几个来源产生，例如，无意识的报告、临床研究和科学出版物。报告的几个关键缺陷与以下相关：

• failures to conduct signal detection activities
• 未能采取措施监测讯号
• failures to incorporate all available data into signal detection activities
• 未能将所有可获得的数据结合至讯号监测措施中
• significant delays in completing signal evaluation
• 在完成讯号评价时严重延误
• failures to address previously reported major inspection findings, resulting in an escalation of the issue (persistent non-compliance)
• 未能说明之前报告的重大检查缺陷，导致问题升级（持续不符合）
  

In some instances the persistent non-compliance had had a measurable impact. Subsequentcompletion of signal detection activities had resulted in new signals being identified and updates to product information.

在一些情况下，持续不符合具有可量测的影响。之后完成的讯号检测措施已经可以识别出新的讯号，对药品信息进行更新。

Further Critical findings were identified in relation to:

还有一些关键缺陷与以下内容有关：

• MAH oversight of the pharmacovigilance system
• 上市许可持有人对药物警戒系统的监管
• pharmacovigilance quality management system
• 药物警戒的质量管理体系
• risk management system
• 风险管理体系
  

A single Critical finding was identified in each of the following areas:

以下领域各只有一个关键缺陷：

• complete system failure
• 系统完全失效
• PSURs (periodic safety update report)
• PSUR（定期安全更新报告）
• case processing
• 案例处理
• submission of false and misleading information to EMA
• 提交了错误的和误导性的信息给EMA
  

There were no Critical findings in relation to non-interventional programmes compared to four reported during the April 2013-March 2014 period.

不干预项目没有关键缺陷，而2013年4月至2014年3月检查期报告了4个。

The topic areas representing the major proportion of inspection findings remain associated with key pharmacovigilance activities and outputs such as ICSR management, signal management and reference safety information.

重大缺陷主要还是关于关键药物警戒活动，以及ICSR管理输出、讯号管理输出和引用安全信息输出方面。

To find out further details please see the complete Pharmacovigilance inspection metrics reportavailable on GOV.UK.

更多细节参见英国药监官网上完整的药物警戒检查指标报告。

摘自http://zhuyujiao1972.blog.163.com/blog/static/98694727201608115335627/