Announcement on Further Strengthening the Work of Technical Evaluation Services for Drug Evaluation
In order to implement the "Opinions of the State Council on Reforming the Approval System for Drug Medical Device Evaluation and Approval" (Guo Fa [2015] No. 44), implement the "Administrative Measures on Drug R&D and Technical Review Communication and Communication (Trial)" by the State Food and Drug Administration ( 2016 No. 94) requires further strengthening the technical review and consultation of pharmaceuticals, optimizing technical consultation procedures, and improving the quality and efficiency of drug review technical consulting services. The CFDA Drug Evaluation Center has launched a network consulting platform on the CDE website. The relevant matters are hereby announced as follows:
First, the CDE website opened a network consulting platform
From now on, applicants can submit a communication meeting application and general technical problem consultation through the “Applicant's Window†on the CDE website. The communication and communication meeting shall be organized by the project manager, and the two parties shall negotiate, prepare and convene in accordance with the relevant requirements of the communication and management methods; consult the general technical issues, and the project manager shall organize the relevant personnel for processing, and within 15 working days. The result will be processed in response to the applicant.
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