CFDA’s Prioritized Review and Approval to Resolve Drug Registration Backlog
In December 2015, the CFDA set forth new policies regarding drug innovation and commercialization. Registration applications for drugs with clear clinical value must meet one of the following circumstances:
- Novel new drugs that have not been launched in or outside China.
- Novel new drugs that will transfer production to China.
- Drugs adopting advanced formulation technologies and innovative therapeutic approaches as well as with clear therapeutic benefits.
- Clinical trial applications (CTA) for drugs with patents expiring in three years and production applications for drugs with patents expiring in one year.
- Synchronized clinical trial applications in the United States and European Union.
- Registration applications for drug products manufactured in China on the same production line that are applying for synchronized marketing approvals in United States and European Union with completed onsite inspections.
- TCMs (including minority medicines) targeting major disease prevention and treatment with clear clinical positioning.
- New drugs listed in the state sciences and technology major programs or national R&D programs.
Registration applications for drugs with clear clinical advantages for the prevention and treatment of the following diseases:
- Viral hepatitis
- Orphan diseases
- Malignant tumors
- Pediatric drugs
- Diseases common to the senile population