BIG EVENT! CFDA CLINICAL TRIAL INSPECTION CANCELLED SO MUCH! HOW IS YOURS?

Dec 4^th, 2015, CFDA has convoked a symposium of nationwide clinical trial data inspection to summarize the previous work and deploy the work of next stage. As we all know, clinical trial is the key point to guarantee the effectiveness and safety of drug/medical device, and the false data of clinical trial will seriously violate regulations and harm people's lives.

Before the new regulations came into force from 2014 June, a lot of drug and medical devices were registered without Chinese clinical trial data (don’t required by old regulations) or with false data, which resulted in a mass of adverse events and even kill people's lives, these poor manufacturers might be lucky to get rid of penalty under the old SFDA supervision system. Nevertheless, CFDA would never want to see this awful phenomenon again. So, to protect the consumers' health and prohibit all false drug/medical devices entering into the market, CFDA was carrying out a thorough investigation and reorganization for manufacturers using false clinical trial data from November.

It was on Nov 11^th, 2015 that CFDA issued an Announcement of Policies for Review and Approval of Registration for Clinical Trial, which has clearly indicated that the action of data fraud will be punished severely. For example, applicant cannot apply for all kind of drug registration within 1 year, as well as same kind within 3 years; CRO will be ordered to rectify and reform within limited time, or even be closed down.

This inspection involved 1429 clinical trial, among which 617 (occupied 43%) had cancelled their clinical trial or been stopped up to now, and according to the reliable news, the actual cancellation rate had increased to 64%. What is more, CFDA has publicized the serious violations of 29 enterprises and 9 CRO, of which 3 CRO have been filed and investigated by CFDA, and 4 CRO have been filed and investigated by corresponding provincial FDA, the rest institutions by Medical Department of General Logistics Department of PLA. There are more than 50 clinical trials are asked to stop because the CRO have serious fraud suspicion (Table 1). Worse than that, there are more than 150 products of 29 enterprises failed to be approved by CFDA because of fraud clinical data (Table 2).

Table 1. Investigated Poor CRO and their Forbidden Clinical Trial No.

CRO Name	Stop Number	CRO Name	Stop Number
广州博济新药临床研究中心有限公司	11	北京万全阳关医药科技有限公司	1
北京乐维生物技术有限公司	7	杭州科人医药技术咨有限公司	1
安徽万邦药业科技有限公司	6	湖南泰格湘雅药物研究有限公司	1
合肥合源药业科技股份有限公司	6	沈阳赛捷医药咨询科技开发有限公司	1
沈阳亿灵医药科技有限公司	5	维欧医药科技发展有限公司	1
江苏令华医药科技有限公司	3	新领先医药科技发展有限公司	1
江苏三才医药科技有限公司	2	北京合力众盈医药科技有限责任公司	1
润东医药研发（上海）有限公司	2

Table 2. 29 Manufacturers' Clinical Trial Failed to Be Approved by CFDA

Enterprise Name	Product Number	Enterprise Name	Product Number
浙江华海药业股份有限公司	19	优胜美特制药有限公司	5
苏州东瑞制药有限公司	11	哈尔滨三联药业有限公司	5
迪莎药业集团有限公司	8	印度瑞迪博士实验室有限公司	4
江苏豪森药业股份有限公司	8	海南全星制药有限公司	4
海南康芝药业股份有限公司	6	海南双层药业股份有限公司	4
宜昌长江药业有限公司	6	海南先锋制药有限公司	4
江苏恒瑞医药股份有限公司	6	海南通用三洋药业有限公司	4
山西量子高科药业有限公司	6	辅仁药业集团有限公司	4
广东彼迪药业有限公司	5	江苏万高药业有限公司	4
广东逸舒制药有限公司	5	江西药都仁和制药有限公司	4
海南灵康制药有限公司	5	山东达因海洋生物制药股份有限公司	4
山东京卫制药有限公司	5	扬子江药业集团有限公司	4
山东齐都药业有限公司	5	南京长奥制药有限公司	4
山东新时代药业有限公司	5	浙江海正药业股份有限公司	4
四川科伦药业有限公司	5

Unfortunately, 浙江华海药业股份有限公司 the top 1 listed on above, all their clinical trial for new products are cancelled or stopped, which means they cannot have new products registered in CFDA at least in the following 3 years.
Therefore, under the tremendous pressure of supervision for clinical trial, a large number of CRO are rectifying and standardizing to avoid being disqualified. In this situation, the clinical trial of drug/medical device will be dramatically affected, because hospitals will be much more careful to take clinical trial cases.

The clinical trial cycle will extend, because：

1.CRA need take more time and effort to find and evaluate the CRO to ensure the clinical trial will be conducted successfully.

2.Hospitals will focus even more intensely on the review of clinical trial protocol to ensure the accuracy and reliability, as well as the rights and interests of subjects.

The cost of clinical trial will be increased. Because:

Clinical trial institutions need add more links of supervision to avoid data fraud and data loss, as well as to ensure adverse event will be reported in time.

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