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In order to implement the reform requirements of "decentralization, management and service", further optimize the business environment, reduce the burden on enterprises, and promote the electronic declaration of drug registration applications, the State Food and Drug Administration organized and drafted the "Announcement on the Implementation of Electronic Application for Drug Registration (Draft for Comments)" and the "Notice on Relevant Requirements for Electronic Declaration of Drug Registration Applications (Draft for Comments)", "Technical Requirements for Electronic CD-ROMs for Application Materials (Draft for Comments)", "Electronic File Structure of Drug Registration Applications (Draft for Comments)" and "Letter of Commitment (Draft for Comments)" (see annex), which is now open to the public for comments
.
Please give feedback to our office
before November 20, 2022.
Contact number: 010-85242409
Email: zhongwch@cde.
org.
cn
Attachments: 1.
Announcement on the implementation of electronic declaration of drug registration applications (Draft for Comments).
2.
Notice on the requirements for electronic declaration of drug registration applications (Draft for Comments) 3.
Technical Requirements for Electronic CD-ROMs for Application Materials (Draft for Comments) 4.
Electronic File Structure of Drug Registration Application (Draft for Solicitation of Comments)5.
Letter of Commitment (Draft for Solicitation of Comments) 6.
Feedback Form
Comprehensive Department of the State Food and Drug Administration
November 4, 2022
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