China Food and Drug Administration (CFDA) has given drugmakers until 25 August to self-audit and authenticate clinical trial data they have included in regulatory filings. The action is intended to root out drugs that are seeking approval on the strength of forged data, a status some think applies to as many as half of all applications in China.

By making drugmakers audit their data and get legal representatives to vouch for their authenticity, CFDA is effectively conducting an arm’s-length vetting of the quality of filings in its backlog. Each company seeking CFDA approval must go over various aspects of its filings, such as the consistency of databases and original records, to show CFDA the data is legitimate. Companies also have the option to withdraw their applications ahead of the deadline.

If some observers are correct, the action could lead to a major shakeup of the list of drugs seeking CFDA approval. “Many applications were based on forged medical charts and exaggerated effectiveness. It’s conservative to say 50% of applications were based on forged data,” Shi Lichen, director of the Dingchen Medical Consultancy, told South China Morning Post. Such applicants now face a choice:  Withdraw their filings or try to trick CFDA.

The regulator plans to work with local authorities to inspect applicants and verify the legitimacy of claims about the reliability of their data. Any company found to have destroyed evidence faces a ban on registering drugs of up to three years, while clinical trial sites proven to have forged data risk having their licenses revoked. The action could help CFDA to reduce its backlog of applications and save its reviewers from wasting their time on fraudulent submissions.

(SOURCE: Regulatory Affairs Professionals Society)

For more detail notice, please visit CFDA Chinese version website: http://www.sfda.gov.cn/WS01/CL0050/124800.html