Over 1,000 Chinese NDAs rejected due to 'fabricated or incomplete clinical trial data'
As Outsourcing-Pharma.com reported at the time, the CFDA issued a mandate that required drug registration applicants to self-inspect and verify clinical trial data to ensure authenticity.
The report was published in Chinese last week by the CFDA and follows a yearlong investigation initiated in 2015.
Read: CFDA: reports of clinical trial data fraud 'not fact based'
According to the Chinese law firm Sidley, the mandate applied to 1,622 pending drug registration applications, covering both imported and local drugs – of which 81% were eventually found to contain fraudulent data, as per the report.
The report, as translated from the original Chinese by WRBM journalist Douglas Yu, explained:
“Ending on Jan. 21, 2016, according to data released by the China Food and Drug Administration (CFDA), 1,184 drug registration applications had been rejected by the CFDA or withdrawn by pharmaceutical enterprises due to fabricated or incomplete clinical trial data. It makes up 81% of the total drugs, excluding the 165 new ones that were exempt from clinical testing.”
Sidley’s press release from 2015 said the investigation was initiated “to ensure authenticity and reliability of the data, as well as proper record-keeping.”
Companies were required to submit self-inspection reports by August 25, 2015 and had up until this time to voluntarily withdraw their registration applications from CFDA.
If false or incomplete data was found, companies “may be banned from filing any drug registration applications with CFDA for a period of three years.”
The Chinese FDA has not responded to a request for comment.
John J. Lewis, senior vice president, Policy and Public Affairs at the Association of Clinical Research Organizations (ACRO) told us, “CROs have two primary responsibilities: to ensure the integrity of data and to protect the safety and welfare of patients. ACRO members adhere assiduously to these principles. Data falsification carries serious regulatory and market consequences and cannot be tolerated.”
NDA backlog in China
China has accrued a massive backlog of drug applications over the past several years – with average review times of three years.
As Christine Yuying Gao, MD, PhD, Certera Strategic Consulting China president and CEO told us in January, the CFDA has 120 employees responsible for technical review, while it receives approximately 8,000 to 10,000 applications each year.
With 20% of the world’s population and only 1.5% of the global drug market, the country has recently taken steps to increase innovation. Specifically, the CFDA recently introduced new procedures for drug registration and approval.