如何通知EMA关于GMP的问题或数据完整性问题

How to inform EMA about GMP Problems or Data Integrity Issues如何通知EMA关于GMP的问题或数据完整性问题

On 17 March 2017 the European Medicines Agency (EMA) released a new policy on the handling of information which has been received from external sources about serious concerns, e.g. related to GMP deviations or Data Integrity issues. The EMA stated in its press release that "since 2013 EMA has received a total of 43 reports that relate for example, to the manufacturing of medicine or the conduct of clinical trials."

2017年3月17日，EMA发布了一份处理从外部接收到的严重关切的新政，例如，关于GMP偏差或数据完整性问题。EMA在其发布消息中声称“自从2013年以来，EMA已收到总共43份有关，如药品生产或临床试验的报告。”

So far there has been no formal procedure in place to handle these cases. This gap has now been closed with the publication of the EMA Policy/0072 entitled: "EMA's handling of information from external sources disclosing alleged improprieties concerning EMA activities related to the authorisation, supervision and maintenance of human and veterinary medicinal products". In this document the EMA describes how reports will be handled and which actions will be taken. In the US a procedure for so called "whistleblowers" is well known in public. However, in Europe very few countries have procedures for individuals to report improprieties to an authority.

截止目前，还没有发布过正式程序来处理这些案件。这种差距现在通过发布“EMA方针/0071标题：EMA处理从外部接收的揭露EMA关于人药和兽药批文、监管和维护的活动有关的可疑不当行为”得到弥合。在此文件中，EMA描述了会如何处理报告，将采取何种措施。在美国，有一个所谓的“告密者”程序广为人知。但是，在欧洲，只有很少国家有这样的程序让个人向药监报告不当的事情。

The document published by the EMA intends to help especially individuals to report their observations if they notice illegal procedures within companies. This might be the case if, for example, raw data has been deleted or adulterated. Such cases of fraud might cause serious risks for patient safety e.g. if a QC test confirms that a product is out of specification and the corresponding data has been deleted or if manufacturing steps have not been performed according to the documentation in the company. In the past years more and more cases have become public about Data Integrity. The policy for external individuals will support them to ensure that the information provided will be treated in a structured manner and that the personal data of the individuals will be treated confidentially.

这份由EMA发布的文件意在帮助尤其是个人，当他们注意到公司内不合法程序时，报告其发现的事情。例如，如果原始数据被删除或篡改，这就可以报告。此类做假案例可能会导致严重的患者安全风险，例如，如果一个QC检测确认了产品不符合质量标准，对应的数据被删除，或者如果生产步骤没有根据公司的文件记录执行。在过去数年，越来越多的关于数据完整性的情况已被公开。该接收外部个人举报的政策将支持他们确保所提供的信息会有程序来处理，个人信息也会保密。

感谢楼主分享，辛苦