On 26 February 2016, the China Food and Drug Administration (the “CFDA”) issued the Opinions on the Implementation of Priority Review and Approval to Resolve Backlogged Drug Registration Applications (the “Opinion”). The Opinion establishes a priority review and approval process for specific drugs which significantly reduces the term of the registration period. 

The Opinion defines the qualified drug registration applications and details the procedure for the priority review and approval process. According to the Opinion, new drug clinical trial applications, new drug market applications and generic drug registrations are entitled to priority review and approval, if the applications: 

  • have apparent clinical value and satisfy seven specific requirements. Such applications include applications for innovative drugs that have not yet been marketed at home or abroad; clinical trial applications that are within three years of the relevant patents’ expiration date and market applications which are within one year of the relevant patents’ expiration date; and clinical trial applications for new drugs for which a clinical trial application has been filed and approved in the U.S. or EU etc.;
  • have an apparent clinical advantage and apply to seven specific diseases including HIV/AIDS, tuberculosis, viral hepatitis, rare diseases, malignant tumours, paediatrics and geriatric diseases;
  • are supplementary applications for generic drugs due to necessary changes in the approved manufacturing processes in order to comply with the consistency evaluation;
  • are generic drug applications which have been actively withdrawn in previous clinical trial inspections and improved following the requirements of the consistency evaluation;
  • are applications for drugs which are urgently demanded for clinical use or in short supply in the market. 

The procedure for the priority review and approval process will be different for new drug clinical trial applications, new drug market applications and generic drug registrations. However, based on the Opinion, the term of the registration period for all three types of application will be significantly reduced. 

This Opinion is favourable for innovative drugs and drugs for specific diseases and patients. This should benefit many multinational pharmaceutical companies. The Opinion also provides a fast track for generic drugs whose relevant patents are soon to expire. 

Please see the Opinion (Chinese only).