PHDS HEALTHCARE RESEARCH Co., Ltd.
Technical requirements for the latest declaration data electronic disc
Release time:
2023-12-12
In order to further improve the quality and efficiency of the production of electronic application materials for drug registration applications, and to standardize the management of electronic application materials, feedback opinions have been taken into account.
In order to further improve the quality and efficiency of the electronic submission of drug registration application materials, standardize the management of electronic submission materials, and in response to feedback, our center has updated the "Technical Requirements for Electronic Discs of Submission Materials" and "Electronic Document Structure for Drug Registration Applications" published on December 2, 2022, forming the "Technical Requirements for Electronic Discs of Submission Materials" (Attachment 1, hereinafter referred to as "Technical Requirements") and "Electronic Document Structure for Drug Registration Applications" (Attachment 2, hereinafter referred to as "Document Structure"), and has developed the "Verification Standards for Electronic Submission Materials" (Attachment 3, hereinafter referred to as "Verification Standards"). The relevant requirements are notified as follows:
I. Main Updates
(1) The "Technical Requirements" clarify the rules and sources for application number coding, adding application numbers for active pharmaceutical ingredients, excipients, and packaging materials; refine the requirements for the medium of electronic submission materials, stating that the discs used to store electronic submission materials must be one-time writable standard 120 archival discs and must not be rewritten; add content regarding the software for producing electronic submission materials and checksums.
(2) The "Document Structure" improves the requirements for file and folder extensions, refines each application item, and fixes its folder structure and path, while also adding a "Clinical Database Folder" and the electronic submission document structure for excipients and packaging materials.
(3) The "Verification Standards" mainly include three parts: basic information, files/folders, and integrity. If the verification of electronic submission materials results in a severity level of "error," it cannot pass verification.
II. Receipt of Electronic Submission Materials
After receiving the discs submitted by the applicant, the Drug Review Center will verify the readable discs according to the "Verification Standards". Discs that pass verification will enter the subsequent process; discs that cannot pass verification will not enter the subsequent process and will be processed according to the destruction procedure. Applicants can check the disc receipt progress and verification report through the "Applicant Window" on the Drug Review Center's website.
III. Regarding Disc Organization
Applicants must submit one complete set of electronic submission materials discs (including clinical trial databases, if applicable) for review as per the requirements of this notice. For the first drug registration application submitted after the implementation of this notice, if there are supplementary materials, only the supplementary content should be submitted.
Except for applications that do not involve verification, such as drug clinical trial applications, overseas production drug re-registration applications, and supplementary applications for direct administrative approval, applicants must also submit one complete set of electronic submission materials discs (including clinical trial databases, if applicable) for verification. For materials involving clinical trial databases, an additional set of clinical trial database discs must be prepared separately. For applications involving generic name approval materials, non-prescription drug suitability review, and label review, there is no longer a requirement to submit a separate set of discs.
IV. Regarding Registration Materials for Excipients and Packaging Materials
Registration materials for excipients and packaging materials should be executed in accordance with the requirements of this notice.
V. Software for Producing Electronic Submission Materials
The electronic submission materials production software (Attachment 4) includes functions such as electronic submission materials signing and verification, and can generate electronic submission materials that meet the requirements. Applicants may voluntarily choose to use the electronic submission materials production software.
This notice will take effect on March 1, 2024. In case of any inconsistency between the "Notice on Requirements for Electronic Submission of Drug Registration Applications" and this notice, this notice shall prevail.
Attachment: 1. Technical Requirements for Electronic Discs of Submission Materials
2. Electronic Document Structure for Drug Registration Applications
3. Verification Standards for Electronic Submission Materials
4. Software for Producing Electronic Submission Materials
5. User Manual for Electronic Submission Materials Production Software
Keyword:
Relevant regulations and policies
Key points and judgment principles for the quality management of non-clinical research of drugs
In order to standardize the on-site inspection work of Good Laboratory Practice (GLP) for non-clinical drug research and improve inspection quality, the "Key Points and Determination Principles for the Inspection of Good Laboratory Practice in Non-Clinical Drug Research" has been formulated in accordance with relevant requirements such as the "Drug Administration Law of the People's Republic of China," "Good Laboratory Practice for Non-Clinical Drug Research," and "Management Measures for the Certification of Good Laboratory Practice for Non-Clinical Drug Research."
2024-11-22
Technical requirements for the latest declaration data electronic disc
In order to further improve the quality and efficiency of the preparation of electronic application materials for drug registration, and to standardize the management of electronic application materials, our center has updated the "Technical Requirements for Electronic Discs of Application Materials" and "Structure of Electronic Documents for Drug Registration Applications" published on December 2, 2022, based on feedback.
2024-11-22
In December 2023, PHDS HEALTHCARE RESEARCH Co., Ltd. was elected as the vice president unit of the China Food and Drug Enterprise Quality Safety Promotion Association, as well as the vice chairman of its subordinate digital professional committee (Certificate No.: Zhong Shi Yao An Cu Hui Zheng Zi 798). The election and award ceremony took place at the Three Gorges Hospital of Chongqing Medical University.
2024-11-22
On March 26-27, 2024, the China Wuxi Global Oral Forum and the China Food and Drug Promotion Association High-Quality Development Conference, guided by the Wuxi Municipal People's Government and the Wuxi Council for the Promotion of International Trade, and organized by the China Food and Drug Promotion Association and the Oral Health Committee of the China Food and Drug Promotion Association, will be grandly held at the Wuxi International Conference Center.
2024-11-22
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