China Priority Acceptance Service for Innovative Drug Applications launched by the CDE

China priority acceptance service for innovative drug marketing applications has been introduced by the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) on October 24, 2024. Effective from November 1, 2024, this "priority acceptance" service focuses on products deemed innovative or those eligible for the priority review or conditional approval pathways.By providing front-line support for specific application aspects, the CMDE seeks to encourage drug innovation, promote high-quality development in the biomedical sector, and expedite the market launch of new and effective drugs.

Key Highlights of the Priority Acceptance Service

1) Purpose

Assist applicants in resolving issues related to the acceptance process of listing authorization applications, including policies and regulations, application procedures, and supporting documents, to improve the one-time acceptance rate of listing applications.

2) Scope

When submitting an application for marketing authorization for an innovative drug.
When submitting an application for marketing authorization for varieties that can be included in the priority review and approval procedures or the conditional approval procedures confirmed through communication and exchange meeting.

Regional branches, including the Yangtze River Delta Branch Center in Shanghai and the Greater Bay Area Branch Center in Shenzhen, will support regional applicants with this service.

3) Application Process

To initiate the priority acceptance service, applicants must complete a few key steps before formally submitting their marketing application. Appointment RequestApplicants should first schedule an appointment via the CDE website under the “Applicant's Window.” This step requires applicants to submit basic product information, outline any specific questions they may have regarding the acceptance process, and upload a power of attorney document to authorize the request. Supporting DocumentationIn preparation for the consultation, applicants must compile essential supporting materials on a CDE. This includes application forms, self-inspection checklists, relevant modules (for chemical and biological drugs), administrative files, and summaries of the main issues and questions to be discussed. These documents are necessary for a productive consultation. face-to-face consultationsEvery Wednesday, applicants can attend in-person consultations at the CDE or at regional branch centers in the Yangtze River Delta (Shanghai) and Greater Bay Area (Shenzhen). During these sessions, NMPA staff will review the submitted documents, address procedural and regulatory questions, and provide feedback.For any issues requiring additional review, NMPA staff will follow up promptly. These consultations help ensure that applicants are well-prepared for their final submission, ultimately improving the likelihood of a smooth acceptance process. Service Timing and LocationsConsultations take place every Wednesday, with two sessions available: 9:00–11:30 am and 1:30–4:00 pm Applicants can attend sessions at the CDE office in Beijing or at regional offices in Shanghai and Shenzhen, enabling convenient access to the service across major biomedical hubs. This structure is designed to accommodate applicants from different regions, enhancing accessibility and support.

Benefits for Drug Manufacturers

For regulatory affairs managers in pharmaceutical companies, this new service offers significant advantages by allowing them to clarify acceptance requirements before formally submitting applications. The priority acceptance service provides a clear pathway to engage with the NMPA early on, reducing the risk of submission errors and improving the likelihood of first-time acceptance.Managers can thereby streamline the application process, minimize delays, and potentially accelerate their product's journey to market.