IBM Clinical Development Blog

Chinese FDA Tightens Regulatory Controls on Trial Data

[fa icon="calendar"] Aug 5, 2015 3:15:00 PM / by Amy Young

Topics: Regulations, China

Compliance with self-inspection mandate required by August 25th

shanghai

The China Food and Drug Administration (CFDA) is making a push to ensure the accuracy of clinical trial data and drug quality (as well as proper record-keeping) for its 1,622 currently pending drug registration applications. This includes both imported and local drugs. 

On July 22, 2015, a Circular was issued to applicants, requiring them to conduct a self-audit and submit an electronic inspection form by August 25th. According to industry sources, this move has caught some firms by surprise. If companies are not able to comply with this mandate - or if their self-audit identifies non-compliant data - they may voluntarily withdraw their registration applications from CFDA by the same deadline. 

According to the law firm Sidley Austin, the self-inspection must include: 

  • A comparison of the locked database and original data, to look for discrepancies (any differences must be explained); 
  • Maintenance records of testing instruments (such as HPLC, LC-MS/MS);
  • Evidence of installment and operation of the audit trail module of data management software (if you're an eCOS user, you're already compliant with this one); 
  • Compliance with the inclusion and exclusion criteria for patients in clinical trials;
  • Data on clinical trial protocol deviations and exclusions, serious adverse events, information on patient visits and lab testing;
  • Records related to investigational products and comparator products, including relevant invoices, records and samples;
  • Records related to the collection, storage, and analysis of biological samples
  • Review of clinical trial protocol compliance by all parties.

The CFDA has also announced that it will conduct further verification (including unannounced on-site inspections) based on the self-inspection reports. Non-compliance could lead to a 3-year ban from filing any drug registration applications with CFDA.

If you're an eCOS customer affected by the Chinese FDA mandate, good news: Many aspects of our platform will help make your self-inspection easier. Should you have any questions, our international team is happy to talk to you! Just send an email to Simon Hawken, our Director of International Sales (Simon.Hawken@eclinicalos.com)  or David Wu, our Business Development Representative in China (David.Wu@eclinicalos.com). David is located in our Shanghai office and can communicate in Chinese, if you prefer.   

To read this blog post in Chinese, scroll down. 


 

825日前完成合规性自查

中国国家食品药品监督管理总局(CFDA)针对现有1,622个待审药品注册申请加大监管力度,以保证临床数据的准确性和药品质量(包括原始数据和记录的保存)。名单包括本地申报生产或进口待审药品。

在2015年7月22日,该项公告发布给了申请人,要求他们展开自查并与8月25日前提交电子自查表。根据行业相关反馈,这一举动震惊了许多公司。如果这些公司不能遵守这一规定,或者他们在自查中发现了不合规的数据,他们能够在同一截止日期前自愿撤回这些向CFDA提交的注册申请。

根据Sidley Austin律师事务所的信息,这些自查必须包括:

  • 核对锁定的数据库与原始数据一致性,数据锁定后是否有修改(任何修改必须加以说明)
  • 生物样本分析测试仪器(如HPLC、LC-MS/MS)等主要的试验仪器设备运行和维护记录
  • 数据管理软件稽查模块的安装及其运行说明(如果您是eCOS用户,您已经符合该项要求)
  • 临床试验受试者入选和排除标准的合规性
  • 临床试验方案违背例数、剔除例数、严重不良事件例数等关键数据,受试者就诊信息、用药及检查化验信息
  • 试验药物和对照药品的信息,包括相关票据、记录、留样
  • 生物样本的采集、保存、分析过程相关的记录
  • 有关方在临床试验项目中主要职责的落实情况、合规情况

CFDA已经通告其将基于企业自查报告自查的基础上展开进一步的核查(包括不预先通知的飞行检查)。对于不合规的相关申请人,CFDA 3年内不受理其申请。

如果您是eCOS的用户,您正关注CFDA的该项公告,告诉您好消息是我们的平台能更高效快捷地帮助您完成自查。如果您有任何问题,我们的国际商务发展团队会乐于与您沟通。您可以发邮件给Simon Hawken,国际商务发展团队VP(Simon.Hawken@eclinicalos.com) 或David Wu 中国区商务发展总监(David.Wu@eclinicalos.com),David Wu 在eCOS上海办公室办公,可以与您中文交流。

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Amy Young
Written by Amy Young