On Jan. 11, 2023, China Center for Drug Evaluation (CDE) released 10 Q&As, including nine questions on the electronic submission of drug applications and one on the application of overseas drugs for China’s marketing authorization.

Related: China Requires Electronic Submission of All Drug Registration Application Documents from Jan. 1, 2023

ChemLinked BaiPharm Portal translated the Q&As for your reference. In case of any discrepancies between the English translation and the original Chinese text, the original shall prevail.

Q1: Does the applicant have to submit application documents in paper if the application was accepted by CDE after format review, and the application was received by CDE before China National Medical Products Administration (NMPA)’s Announcement on Implementing Electronic Submission of Drug Registration Applications took effect on Jan. 1, 2023? For example, the application was signed for by CDE on Dec. 30, 2022, and was accepted on Jan. 6, 2023.

A1: The applicant is required to submit the paper documents to CDE within five workdays after acceptance according to the Announcement on CDE’s Adjustment of the Work Pattern for Application Acceptance and the Requirements for Receiving Drug Registration Application Documents During the COVID-19 Epidemic, to avoid hobbling CDE to complete the technical review on schedule.

For applications submitted on or after Jan. 1, 2023, applicants shall follow the Announcement on Implementing Electronic Submission of Drug Registration Applications.

Q2: What does “the supplemental documents during the review” refer to in the Announcement on Implementing Electronic Submission of Drug Applications and the Announcement on the Requirements for the Electronic Submission of Drug Registration Applications?

A2: It refers to the supplemental documents, stability study documents, and renewed certification documents that are submitted during the review.

Q3: After electronic submission is required for all drug applications, in what form should the stability study documents be submitted during the review?

A3: According to the Announcement on the Requirements Relevant to the Electronic Submission of Drug Registration Applications, such documents shall be submitted as follows.

Q4: As the electronic submission has been required since Jan. 1, 2023, does the applicant still need to fill in the information relevant to paper documents, e.g., the number of paper document packages in the self-review form?

A4: The applicant can indicate “not applicable” at the corresponding information item.

Q5: What documents do the electronic documents for the administrative permission of acceptance include?

A5: It mainly includes:

–       the letter of signing and receiving the application (meaning the application dossier has been received by technical experts at CDE);

–       the acceptance notice (meaning the application is deemed complete in the preliminary review and permitted to enter the subsequent review);

–       the fee-paying notice for administrative permission (requiring the applicant to finish the payment);

–       the deficiency letter (meaning the application documents are deficient, thus CDE requires the applicant to submit the documents that are complete and correct);

–       the testing notice (requiring the applicant to apply for drug testing);

–       the rejection letter (meaning the application is rejected by CDE);

–       the receipt notice (meaning the application has been received by CDE’s mail office), etc.

Q6: As the electronic submission of applications is required from Jan. 1, 2023, does the applicant need to include its legal representative’s digital signature in the drug registration application form?

Q7: Before submitting the application dossier, how should the applicant fill in and submit the application-related information (e.g., express mail information) via the Applicant’s Window (CDE’s online channel for applicants to submit information)?

Q8: What are the requirements for the number of compact disks containing the documents submitted by the applicant?

Q9: In terms of the compact disks for submitting different types of dossiers, what are the requirements for the sealing, jewel case cover, and file cover?

Q10: What should the applicant of an overseas drug pay attention to when collecting the drug quality standards according to the format required by the currently effective Chinese Pharmacopoeia 2020 Edition?

[Read the full answers at BaiPharm]

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