ECA新闻20150506：数据完整性---印度政府使EU承受压力

ECA新闻20150506：数据完整性---印度政府使EU承受压力

2015-05-07 07:29:56|  分类： ECA新闻|举报|字号 [url=]订阅[/url]

GMP News
06/05/2015

Data Integrity - Indian Government puts EU under pressure

数据完整性---印度政府使EU承受压力

One of the largest scandals with regard to data integrity and data manipulation has been detected by French Inspectors of the Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM) in India. On 19-23 May 2014 an inspection took place at GVK Biosciences Private Limited (GVK Bio), Swamajayanthi Commercial Complex, Ammeerpet, Hyderabad 500 038, India.

在2014年5月19-23日对印度GVK生物科学公司的检查中，法国药监（ANSM）在检查中发现了印度关于数据完整性和数据造假的最大丑闻。

The inspection revealed that GVK falsified electrocardiograms which had been used in a clinical trial. The inspectors found a systematic nature of falsification over an extended period of time involving many employees of the company. At least 10 individuals were involved in these data falsification activities between at least July 2008 and 2013. The staff was not adequately trained and did not understand the importance of data integrity. It is obvious that clinical trials performed at GVK can no longer serve as a basis to support a marketing authorisation. Therefore, EMA had no other choice than to suspend 700 marketing authorisations in the EU in January 2015.

检查发现GVK伪造了心电图用于临床试验资料。检查人员发现系统性做假覆盖了很长的时间段以及多名雇员。至少有10个人被卷入这些2008年7月至2013年期间数据伪造行为中。其员工未接受足够铁培训，不明白数据完整性的重要性。显然，在GVK所进行的临床试验不能再支持上市许可了。这样，EMA没有其它选择，只能在2015年撤销了欧盟700张上市许可。

It is a kind of a surprise that Indian Government and Authority who failed to establish adequate controls do not take the necessary steps against GVK and other similar organisations. Moreover, as Reuters reports in a recent article, the Indian Goverment wants to take commercial and legal action against the EMA decision. This step will possibly cause the opposite of what Indian Government wants to achieve. The confidence in the Indian willingness to fight against non-compliance and falsification of data is gone. Companies in Europe and the US need to verify whether current data from India either used for clinical trials or for GMP documentation have been generated without any manipulations. Future management decisions about using regulated services from India will be impacted by the activites of Indian Government. Without Indian Authorities fighting against data manipulation and falsification the trust in data from India will not persist. For the time being not only authorities worldwide but also companies will have to establish comprehensive controls to make sure that quality, integrity and last but not least also the business will not be affected. The financial impact for all concerned companies is significant.

让人吃惊的是印度政府和药监部门没有建议足够的控制，没有对GVK和其它类似组织采取必要的手段。更有甚者，在REUTERS最近的一份报道中说，印度政府想要采取商业和法律措施来反对EMA的决定。这样的行为将可能让印度政府所作所为适得其反。对印度与不符合GMP和伪造数据的信任已经消失。欧洲和美国公司需要核实其仍在使用中的从印度获得用于临床试验，或用于GMP文件记录的数据是否有作假。将来是否使用印度法规服务的管理层决定将受到印度政府行为的影响。如果印度药监部门不与数据做假做斗争，那么对来自印度的数据的信任将不复存在。目前，不仅是全球药监部门，还有公司都不得不建立综合控制来保证质量、完整性和业务不受影响。所涉及的公司的经济影响将是巨大的。