BIG EVENT! CFDA CLINICAL TRIAL INSPECTION CANCELLED SO MUCH! HOW IS YOURS? - Regulatory News - Medical Devices

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
廣州博濟新藥臨床研究中心有限公司	11	北京萬全陽關醫藥科技有限公司	1
北京樂維生物技術有限公司	7	杭州科人醫藥技術咨有限公司	1
安徽萬邦藥業科技有限公司	6	湖南泰格湘雅藥物研究有限公司	1
合肥合源藥業科技股份有限公司	6	沈陽賽捷醫藥咨詢科技開發有限公司	1
沈陽億靈醫藥科技有限公司	5	維歐醫藥科技發展有限公司	1
江蘇令華醫藥科技有限公司	3	新領先醫藥科技發展有限公司	1
江蘇三才醫藥科技有限公司	2	北京合力眾盈醫藥科技有限責任公司	1
潤東醫藥研發（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
浙江華海藥業股份有限公司	19	優勝美特制藥有限公司	5
蘇州東瑞制藥有限公司	11	哈爾濱三聯藥業有限公司	5
迪莎藥業集團有限公司	8	印度瑞迪博士實驗室有限公司	4
江蘇豪森藥業股份有限公司	8	海南全星制藥有限公司	4
海南康芝藥業股份有限公司	6	海南雙層藥業股份有限公司	4
宜昌長江藥業有限公司	6	海南先鋒制藥有限公司	4
江蘇恒瑞醫藥股份有限公司	6	海南通用三洋藥業有限公司	4
山西量子高科藥業有限公司	6	輔仁藥業集團有限公司	4
廣東彼迪藥業有限公司	5	江蘇萬高藥業有限公司	4
廣東逸舒制藥有限公司	5	江西藥都仁和制藥有限公司	4
海南靈康制藥有限公司	5	山東達因海洋生物制藥股份有限公司	4
山東京衛制藥有限公司	5	揚子江藥業集團有限公司	4
山東齊都藥業有限公司	5	南京長奧制藥有限公司	4
山東新時代藥業有限公司	5	浙江海正藥業股份有限公司	4
四川科倫藥業有限公司	5

Unfortunately, 浙江華海藥業股份有限公司 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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