China: CDE Announces Updates for Electronic Submission of Drug Registration Application (1 March 2024)

The Centre for Drug Evaluation (CDE) reviews its management of electronic submission and electronic common technical dossier (eCTD) structure. Also, it reveals Verification Standards for Electronic Application Materials categorized under the regulatory electronic document. This change implementation aims at quality and efficiency enhancement for producing electronic application materials for drug registration applications and to standardize electronic documentation management. This notice will be effectively implemented starting from 1 March 2024.

1. There are 3 regulatory documents involved with the updates:

Technical Requirements for Electronic Discs of Application Materials (“Technical Requirements”)

• The updates define the numbering rules, acquire the application numbers, and add the application numbers for raw ingredients, pharmaceutical excipients, and packaging materials

• Compact disk requirements for electronic application materials (for storing data): use Standard 120 file-level CD-ROM with no options for re-writing, only write-once, may include additional software for data production (optional)

Electronic Document Structure for Drug Registration Applications (“Document Structure”)

• Improvise the requirements for file and folder expansion

• Review each application item and their folder’s structure and path

• Adding new “clinical database folder” and electronic files for pharmaceutical excipients and pharmaceutical packaging materials

Verification Standards for Electronic Application Materials (“Verification Standards”)

• Divided into 3 parts: basic information, files/folders, and integrity

• The electronic verification will not pass after verifying the electronic declaration materials (CD submitted by the applicants) with several errors

• If the electronic declaration materials pass the verification, the CD will go through the subsequent process.

• Applicants may check the verification progress via the “Applicant Window” on the CDE website

2. Compact Disk Sorting

• Applicants are required to submit one completed compact disk (including the clinical trial database, if required) for CDE inspection

• For applications with the verification exception (drug clinical trial applications, overseas-produced drug re-registration applications, supplemental applications that directly seek administrative approval), applicants are required to submit one completed compact disk (including clinical database, if required) for the Centre for Food and Drug Administration (CFDA) inspection

• Any first-time drug registration application submissions after 1 March 2024, only supplementary information is required to be submitted

CDE informs that applicants can voluntarily choose to use the electronic declaration data production software with built-in features of signing and verification that help to generate declaration materials equivalent to the requirements needed.

Source: Centre of Drug Evaluation (CDE)

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