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).

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.