Effective March 1, 2024! The CDE issues a notice announcing the release of documents including the "Technical Requirements for Electronic Disks Containing Submission Materials."

To further enhance the quality and efficiency of preparing electronic submission documents for drug registration applications and to standardize the management of such electronic documents, and taking into account feedback received, our Center has updated the “Technical Requirements for Electronic Disks Containing Submission Documents” and the “Electronic Document Structure for Drug Registration Applications,” originally issued on December 2, 2022. As a result, we have developed the “Technical Requirements for Electronic Disks Containing Submission Documents” (Attachment 1, hereinafter referred to as the “Technical Requirements”) and the “Electronic Document Structure for Drug Registration Applications” (Attachment 2, hereinafter referred to as the “Document Structure”). In addition, we have established the “Validation Standards for Electronic Submission Documents” (Attachment 3, hereinafter referred to as the “Validation Standards”). We hereby notify you of the relevant requirements as follows:

        I. Main Update Contents

(1) The “Technical Requirements” clearly define the rules for application number assignment and the procedures for obtaining such numbers, and introduce application numbers for active pharmaceutical ingredients, pharmaceutical excipients, and pharmaceutical packaging materials. It also refines the requirements for media used to submit electronic documentation: optical discs used to store electronic submission files must be write-once, standard 120-archive-grade discs and may not be repeatedly rewritten or erased. Additionally, it includes provisions regarding software for preparing electronic submission documents and checksum verification methods.

(2) The “Document Structure” has refined the requirements for file and folder extensions, detailed each application item, and standardized the folder structure and paths. Additionally, it has introduced a “Clinical Database Folder” as well as an electronic submission document structure for pharmaceutical excipients and packaging materials.

(3) The “Validation Standards” primarily consist of three components: basic information, files/folders, and integrity. If the electronic submission materials validation yields a result classified as “error” with a severity level of “critical,” the validation will not be passed.

        II. Receiving Electronically Submitted Documents

After receiving the CD submitted by the applicant, the Drug Review Center will verify CDs that can be read normally according to the “Verification Standards.” CDs that pass the verification will proceed to the next stage; CDs that fail the verification will not be allowed to proceed and will be disposed of in accordance with the destruction procedures. Applicants can check the progress of CD receipt and the verification report through the “Applicant’s Window” on the Drug Review Center’s website.

        III. Regarding Disc Organization

The applicant shall submit one complete set of electronic submission data on CD-ROM (including the clinical trial database, if applicable) as required by this notice for review and evaluation. For drug registration applications submitted for the first time after the implementation of this notice, if supplementary materials are requested, only the supplemented content shall be submitted.

Except for applications that do not involve verification—such as applications for clinical trials of pharmaceuticals, re-registration applications for pharmaceuticals manufactured overseas, and supplementary applications subject to direct administrative approval—applicants must also submit, concurrently, one complete set of electronic submission data on a CD-ROM (including the clinical trial database, if applicable) for verification purposes. If the application involves clinical trial database materials, applicants must prepare an additional separate set of CD-ROMs containing the clinical trial database. For applications involving generic name approval, as well as those requiring over-the-counter drug suitability reviews and package insert reviews, there is no longer any requirement to submit a separate set of CD-ROMs.

        IV. Regarding Registration Data for Pharmaceutical Excipients and Pharmaceutical Packaging Materials

Registration data for pharmaceutical excipients and packaging materials shall be submitted in accordance with the requirements of this notice.

        V. Electronic Filing Data Preparation Software

The electronic filing document preparation software (Attachment 4) is equipped with functions such as electronic signature and verification of filing documents, enabling it to generate electronic filing documents that meet the required standards. Applicants may voluntarily choose to use this software for preparing their electronic filing documents.

This notice shall take effect as of March 1, 2024. In the event of any inconsistency between this notice and the “Notice on Requirements for Electronic Submission of Drug Registration Applications,” this notice shall prevail.

Attachment: 1. Technical Requirements for the Electronic Disc Containing Application Materials

2. Structure of Electronic Documents for Drug Registration Applications

3. Standards for Verifying Electronically Submitted Documents

                 4.  Electronic Filing Data Preparation Software

5. User Manual for Electronic Filing Data Preparation Software

Center for Drug Evaluation, National Medical Products Administration

December 11, 2023

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