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Effective November 1, 2024! Notice on Providing Early-Stage Acceptance Services for Innovative Drugs and Varieties That Have Been Confirmed Through Communication and Consultation as Eligible for Priority Review and Approval Procedures and Conditional Approval Procedures.
Release time:
2024-10-24 16:15
Source:
https://www.cde.org.cn/main/news/viewInfoCommon/9eba0fc4a6b7a2fcea0a0922dcbb9426
To further encourage innovation in pharmaceutical R&D, promote high-quality development of the biopharmaceutical industry, and accelerate the launch of new and effective drugs, with the approval of the National Medical Products Administration (NMPA), starting November 1, 2024, applicants for marketing authorization of innovative drugs—as well as those drugs that have been confirmed through communication and consultation to be eligible for priority review and approval procedures and conditional approval procedures—will be provided with early-stage acceptance services. Prior to submitting their marketing authorization applications, applicants may submit requests for early-stage acceptance services to the Center for Drug Evaluation of the NMPA (hereinafter referred to as the CDE), the Yangtze River Delta Sub-center of the NMPA’s Center for Drug Evaluation and Inspection (hereinafter referred to as the Yangtze River Delta Sub-center), or the Greater Bay Area Sub-center of the NMPA’s Center for Drug Evaluation and Inspection (hereinafter referred to as the Greater Bay Area Sub-center). The specific requirements are hereby notified as follows:
I. Scope of Frontline Service Acceptance
The front-end acceptance service primarily addresses issues related to policies, regulations, application procedures, and supporting documentation involved in the acceptance stage of marketing authorization applications for innovative drugs as well as products that have been confirmed through communication and consultation to be eligible for priority review and approval procedures and conditional approval procedures. This service does not cover issues related to technical reviews.
The Yangtze River Delta Sub-center for Pharmaceuticals and the Greater Bay Area Sub-center for Pharmaceuticals provide pre-acceptance services to pharmaceutical registration applicants within their respective regions.
II. Procedures and Requirements for Applying for and Processing Frontline Services
(1) Appointment Application
Before submitting the marketing authorization application, the applicant shall use the “Applicant’s Window” on the Drug Review Center’s website to submit a reservation request for early acceptance services, provide information about the product to be discussed and the specific questions to be addressed, and upload the letter of authorization.
(2) Supporting Materials
To ensure high-quality, proactive service during the application process, applicants are required to submit certain supporting documents in CD format when communicating face-to-face. These documents include, but are not limited to, the application form, self-assessment checklist, and a portion of the module (applicable to chemical drugs and biological products), administrative documents, and the pharmaceutical information section (applicable to traditional Chinese medicines), as well as a brief overview of the issues to be discussed and proposed work recommendations.
(3) Face-to-face communication
Every Wednesday is the face-to-face public day for priority service acceptance. The Drug Review Center and its two drug sub-centers will collectively communicate with applicants whose appointment requests submitted within the past five days meet the scope of priority service.
The受理 personnel will complete the review of the submitted documents on-site and provide feedback to the applicant. The electronic disc will also be returned together with the documents. For cases where a response cannot be provided on-site due to issues related to policies and regulations, the Drug Review Center and the two drug sub-centers will promptly follow up with updates on the processing progress and their recommendations.
When submitting the marketing authorization application, the applicant shall prepare and organize the submission documents in accordance with current regulations and the requirements for early-stage service communication, thereby increasing the likelihood of the application being approved on the first submission.
III. Service Hours and Locations for Front-End Acceptance
(1) Frontline Service Hours for Acceptance
Every Wednesday from 9:00 to 11:30 and from 13:30 to 16:00.
(2) Frontline Service Locations for Acceptance
Drug Review Center: Building 1, Area 2, No. 22 Guangde Avenue, Beijing Economic-Technological Development Zone.
Drug Yangtze River Delta Sub-center: Building 2, 1st Floor, No. 58 Haiqu Road, Zhangjiang Town, Pudong New Area, Shanghai.
Pharmaceutical Greater Bay Area Sub-center: Room 0906, 9th Floor, Building G, Shenzhen-Hong Kong International Science and Technology Park, Futian District, Shenzhen City, Guangdong Province.
Center for Drug Evaluation, National Medical Products Administration
National Medical Products Administration Drug Review and Inspection Yangtze River Delta Branch Center
National Medical Products Administration Drug Review and Inspection Greater Bay Area Branch Center
October 24, 2024
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