China Center for Drug Evaluation (CDE) published six questions and answers on 3rd Mar. The Q&As are regarding drug master file (China DMF) filing (Q1-Q2) and electronic submissions for drug applications (Q3-Q6).
Accestra provided English translations of the Q&As. In the event of any inconsistencies between the translated text and the original Chinese version, the original will take precedence.
Q1: In the case of a modification to an authorized API that has been previously notified, and the alteration relates to the publicly disclosed DMF data on the CDE website, how should the API DMF submitter update the corresponding public information?
When applying for the change, it is advised that the API DMF submitter accurately and completely fill in the API filing number under Item No. 22 “Original Drug Approval/Filling Number,” so that the relevant public information (company name, company address, etc.) on the filing platform will be updated and synchronized.
A1: As per Article 19 of the Administrative Measures for Post-approval Changes of Drugs (Interim), to modify an authorized API, the API DMF submitter must identify the administrative category of the change and carry out the change after obtaining approval or filing. The categorization, approval, and filing must adhere to current regulations on drug registration administration, Good Manufacturing Practice (GMP) for Drugs, technical guidelines, and the mentioned Administrative Measures.
The API submitter should promptly update the change information on the DMF filing platform. To facilitate API DMF submitters, CDE has enhanced the system and achieved synchronized updates of filed data and publicly disclosed information on the China DMF filing platform.
Q2: In the case of modifications to pharmaceutical excipients or packaging materials that involve the disclosed information on the China DMF filing platform, what is the procedure for the filer to update the change information on the platform?
A2: The filer must select the “update” button located under the filing number through the “Applicant’s Window” and submit a compact disk containing the necessary documents. Once the documents have been approved by CDE, the filer should then update the pertinent information on the filing platform.
Q3: What are the typical issues that arise when applicants utilize e-signatures for electronic submission of drug applications?
A3: There are two main issues:
a) The applicant attempts to modify the content and attributes of the file after applying the e-signature to the PDF file. These modifications may involve adding, deleting, or altering the content; compressing, splitting, or merging the files; using optical character recognition (OCR) on the text, etc.
It is suggested that the applicant include the e-signature in the file after making all the necessary changes.
b) The applicant did not properly incorporate an effective e-signature into the PDF file as per the Announcement on the Requirements of Electronic Submission of Drug Registration Applications. This issue may result in e-signatures failing to pass verification due to incorrect signature-issuing institutions, missing or erroneous e-signatures, and/or other factors.
It is advised that the applicant review the requirements outlined in the aforementioned Announcement. Prior to submitting the compact discs, the applicant should check the signed files to ensure that the e-signatures are valid.
Q4: After finalizing the files and transferring them to CDs as per the Announcement on the Requirements of Electronic Submission of Drug Registration Applications, what aspects should the applicant focus on?
A4: Applicants must:
a) Confirm the validity of the e-signatures on the application files and conduct a thorough computer virus scan; and
b) Ascertain that every file on the CDs is intact, accessible, and duplicable to ensure the dossier’s completeness.
Q5: Which file format should be used by applicants when submitting documents electronically?
A5: As per the No. 1 Appendix to the Announcement on Electronic Submission Requirements for Drug Registration Applications, applicants must submit their files in PDF format (acceptable versions: 1.4, 1.5, 1.6, 1.7, PDF/A-1, and PDF/A-2). The PDF files should be easily searchable and allow copying of content. It is recommended that applicants convert their original documents (e.g., Word files) to PDF format in accordance with the Announcement.For clinical trial data files, the format should adhere to CDE’s Guidelines on Drug Clinical Trial Data Submission (Trial).
Q6: What is the best way to arrange electronic files and file structure on compact discs for electronic submission of drug applications?
A6: Refer to Appendix No. 2 “Electronic File Structure for Drug Registration Application” in the Announcement on the Requirements of Electronic Submission of Drug Registration Applications.Additionally, the applicant must create a folder called “application information” containing the application (if applicable), a letter of commitment, and other relevant documents.The applicant must arrange the files in the proper sequence and in accordance with the application dossier’s catalog.
Contact Us
For help to determine whether your drug product qualifies for accelerated pathway or queries related to China regulations and registration, please contact: info@accestra.com