The Revised Guidance by China's FDA bodes well for the Drug Industry

On June 3, CFDA (China Food and Drug Administration) released document No. 113, detailing the rules on the refilling and requirements on clinical data.  

Here are the key takeaways of the new guidelines: 

• A withdrawal should be for the whole application which includes other applications that shared the same clinical data or the related API applications if any

• The applicants can refile for manufacturing approvals for the self-withdrawn drugs, after re-conducting clinical trials or providing supplementary data to CFDA based on the relevant requirements

• Clinical trials are required to be reconducted if there is any false clinical data

• All the re-submissions should follow the new classifications of chemical drugs.

• Fees for a re-submission would be the same as the fees of a new application

The revised guidelines for drug approval is a much needed positive catalyst for the Chinese pharmaceutical sector that has been reeling under pressure including pricing pressure, pipeline recall and tax reform.