On Nov. 4, China National Medical Products Administration (NMPA) released a series of draft regulations on electronic drug registration application, requiring application dossiers to be submitted in compact discs instead of paper.1 Public advice and comments are welcomed to be sent to email@example.com before Nov. 20, 2022.
The draft regulations include:
Announcement on Electronic Drug Registration Applications
Announcement on the Requirements for Electronic Drug Registration Applications
Technical Requirements for Compact Discs Containing Application Dossiers
Document Structure of Electronic Drug Registration Applications
Compact Disc Submission
According to Draft 1 Announcement on Electronic Drug Registration Applications, drug registration applications as well as supplemental documents during the review shall be submitted in compact discs from Dec. 1, 2022. For applications submitted in paper before Dec. 1, 2022, supplemental documents submitted during the review can still be in paper. The submission process stays the same as before.
For drug applications submitted in Electronic Common Technical Documents (eCTD) format, the paper documents, previously required by the Announcement on Adopting the eCTD Submission for Drug Registration Applications, will no longer be required. Other requirements in the announcement will still be effective.
Format Review of the Application Dossiers
Draft 2 Announcement on the Requirements for Electronic Drug Registration Applications notes that Center for Drug Evaluation (CDE) will review the application dossier’s format within 5 workdays upon receiving the compact discs.
If the application is accepted, CDE will upload the acceptance letter to the “Drug Affair Application System” and the “Drug eCTD Registration System”. The applicants will be reminded through SMS and can download the letter directly. CDE will NOT send the acceptance letter to the applicant in paper.