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In China, Accelerated Drug Approval is a new pathway established by the National Medical Products Administration (NMPA) for medicinal products urgently needed for public health. The NMPA periodically publishes priority review lists based on the anticipated clinical needs and the potential value of drug candidates. Drug applications selected for priority approvals are reviewed and approved in an expedited manner. Products with appropriate clinical data in early or mid-stage clinical trials are granted conditional marketing authorization to address urgent medical needs.
There are four (04) different categories for Accelerated Drug Approvals in China:
- Breakthrough Therapy: This category is based on priority review and rolling submissions. It applies to innovative or modified new drugs, drugs that prevent life-threatening diseases, and drugs that are superior to existing therapies.
- Conditional Approval: This category is strengthened by Post-approval Changes (PAC) alignment before the New Drug Application (NDA) approval. The drugs that fall under this category are drugs that have an urgent need for treatment of rare diseases, urgently needed drugs in public health, and vaccines in response to a major outbreak.
- Priority Review: The major benefits associated with this class are shortened New Drug Application (NDA) review timelines and priority on inspection, quality testing (QC), and generic name check. Drugs that are eligible for priority review are the ones that are in shortage and urgently needed to treat infectious diseases, conditional approval drugs, and drugs for rare diseases.
- Special Approval: This class includes a different set of drugs that the NMPA chooses to manage public health crises.
With the increased number of drug approvals by the NMPA, this pathway proves to be useful for the successful market entry of drugs in China. Are you planning to market your drugs in China? Reach out to Freyr and avail our end-to-end Regulatory services for a faster market entry. Contact us now!