The National Medical Products Administration (NMPA) has issued a new Announcement extending the Priority Review and Approval Procedure to eligible applications for the marketing authorization of chemical active pharmaceutical ingredients (APIs), further strengthening China's efforts to accelerate access to strategically important pharmaceutical products.
The measure establishes clear eligibility criteria, prioritising APIs supporting medicines already under priority review, first domestic manufacturers replacing overseas supply, technology transfers to domestic production, and APIs identified as being in short supply. It also streamlines the application process by allowing qualifying applicants to request priority review without the need for a separate communication meeting.
The Announcement further enhances China's regulatory framework for API approvals, supporting domestic manufacturing capacity while improving the resilience and efficiency of the pharmaceutical supply chain.