China Raises Drug Clinical Trial Standards

Over the last few years, 80% of the drug clinical trials in China have been withdrawn with their dossiers for product registration from the China Food and Drug Administration (CFDA). Drug companies are worried that fraudulent clinical trial data could get them in trouble. In April 2017, both the CFDA and Supreme Court have released statements concerning clinical trial data fraud. The CFDA document highlights how the regulatory agency plans on dealing with drug companies, contract research organizations (CROs), hospitals, and principal investigators (PIs) involved in using fraudulent data during clinical trials. For pharmaceutical companies, irregularities found in NDA filings will lead to a three year ban on drug filings in the same category, as well as a one year ban on all other drug filings from the same company. For hospitals and PIs, the CFDA could be more lenient, allowing hospitals an opportunity to rectify the issue and easing PI implications. The Supreme Court’s notice explained the criminal offenses involved in fraudulent clinical trials. These efforts are continuation from a 2015 campaign to reinvent industry standards and minimize clinical trial fraud throughout China.