ChemLinked BaiPharm Team translated the Q&As into English. In case of any discrepancies between the English translation and the original Chinese text, the original shall prevail.
Q1: When an approved API is changed and the change has already been notified, if the change involves the publicized DMF information on CDE’s website, how should the active pharmaceutical ingredient (API) DMF filer change the corresponding publicized information?
A1: According to Article 19 of the Administrative Measures for Post-approval Changes of Drugs (Interim), to change an approved API, the API DMF filer shall determine the administrative classification of the change, and implement the change after approval or filing. The classification, approval, and filing shall comply with currently-effective regulations on drug registration administration, Good Manufacturing Practice (GMP) for Drugs, technical guidelines, and the aforementioned Administrative Measures.
The API filer should update the change information at the DMF filing platform in time. For the convenience of API DMF filers, CDE has improved the system and realized the synchronized update of the filed information and the publicized information on the DMF filing platform and.
When filing for the change, it is recommended that the API DMF filer fill in the API filing number under Item No. 22 “Original Drug Approval/Filling Number” completely and accurately, so that the relevant publicized information (company name, company address, etc.) on the filing platform will be updated and synchronized.
Q2: If the changes to pharmaceutical excipients or packaging materials involve the publicized information on the DMF filing platform, how should the filer update the change information at the filing platform?
A2: The filer should click “update” button under the filing number via the “Applicant’s Window”, and send the compact disk which contains the documents. After the documents pass CDE’s review, the filer should update the relevant information on the filing platform.
Q3: When applicants use e-signatures for the electronic submission of drug applications, what are the common problems?
A3: There are two common problems:
1. The applicant intends to change the contents and the attributes of the file after adding the e-signature to the PDF file. The changes may include the addition, deletion, and/or revision of the contents; the compression, split, or combination of the files; optical character recognition (OCR) of the texts, etc.
It is recommended that the applicant add the e-signature to the file AFTER completing the above changes.
2. The applicant did not add an effective e-signature to the PDF file according to the Announcement on the Requirements of Electronic Submission of Drug Registration Applications. This situation will cause that e-signatures fail to pass the verification due to the wrong signature-issuing institution, the absence of or the error in the e-signature, and/or other reasons.
It is recommended that the applicant read the requirements in the above mentioned Announcement. Before submitting the compact disks, the applicant should verify the signed files to ensure the e-signatures are effective.
Q4: What should the applicant pay attention to after completing the files and burning them onto the compact disks according to the Announcement on the Requirements of Electronic Submission of Drug Registration Applications?
A4: The applicants should
1) verify the effectiveness of the e-signatures on the application files, and complete the computer virus scan; and
2) ensure that each file in the compact disks is undamaged, readable, and copyable for the completeness of the dossier.
Q5: What document format can the applicant use when preparing the files for electronic submission?
A5: According to the requirements in the No. 1 Appendix to the Announcement on the Requirements of Electronic Submission of Drug Registration Applications, the application files should be in PDF format (permitted version: 1.4, 1.5, 1.6, 1.7, PDF/A-1, and PDF/A-2). The contents in the PDF files should be copyable and searchable. It is advised that the applicant convert the original documents (e.g., word files) into PDF files according to the Announcement.
The format of clinical trial data files should follow CDE’s Guidelines on the Drug Clinical Trial Data Submission (Trial).
Q6: How to organize the electronic files and the file structure in the compact disks for electronic submission of drug applications?
A6: No. 2 Appendix “Electronic File Structure for Drug Registration Application” to the Announcement on the Requirements of Electronic Submission of Drug Registration Applications.
Also, the applicant should create an “application information” folder to include the application (if any), letter of commitment, etc.
The applicant should put the files in required order and in line with the catalog of the application dossier.
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