To begin, let me give you an overview of China eCTD. The discussion about China eCTD among the industry and the Global regulatory solution supplier started in 2015. To smoothly implement the eCTD in China, the Health Authority (HA) has three versions of eCTD guidance, technical specifications, and the validation criteria for public comments, which were issued and collected in 2017, 2019, and 2020, respectively.
To note, the most up to date versions for drug eCTD guidance, technical specifications, and the validation criteria, was issued on September 21st, 2020.
China eCTD Requirements – Envelope Elements:
First, let me introduce the envelope elements. For China eCTD submissions, limited information is required in the envelope information – Application Type and Product Type.
The envelope information has been divided into three levels – Application, Regulatory Activity, and Sequence. The product number in the application level is a unique concept, and it will be explained in the next section.
Similar to US eCTD submissions, the concept of regulatory activity has been introduced into China eCTD submissions to grow the submissions for the same regulatory purpose by indicating the same sequence numbers.
Some of the envelope elements are managed by control vocabularies. There are two sequence types we would like to bring your attention to – withdraw and reformat.
For withdrawal submissions, not only is the withdrawal statement needed to be submitted, but applicants also need to revert the life cycle status for all submitted documents in this particular regulatory activity to the previous status.
For the reformat submission, it is also referred to as baseline submission. It is recommended to submit the module 1, module 2, and module 3 documents before the transition of the NDA application into eCTD format.
China eCTD Requirements – Numbering Management:
Besides the publication and sequence numbers, the product number is also used in China eCTD submissions. The product number is a new concept used by China Health Authority (HA) to reflect a unique identifier used to identify the applicant, active ingredient (API), and dosage form.
Each application will start with sequence 0000 and will need to be submitted in numerical order.
China eCTD Requirements – Sample of Envelope Information in Regional XML:
The sample is how the information looks within the regional XML. Both envelope elements and M1 node elements are displayed in Chinese.
China eCTD Requirements – Bilingual Submission:
Chinese bilingual submissions are required in China. All documents in non-Chinese languages need to be translated to Chinese, and both the original document and translated document need to be included in one submission.
The documents in Chinese require full navigation and will serve as a review document. The original non-Chinese document will serve as a reference document. The original one and the translated one will be submitted in the same section but placed in different leaf elements. It will be distinguished by language attributes in the XML.
China eCTD Requirements – Electronic Seal:
The Electronic Seal is also another specific feature of the China eCTD requirements. The electronic seal we mentioned here is the electronic company official seal that applies to the electronic seal in the PDF file, and is authenticated by the Health Authority.
The electronic company seal is required to be on the application form and cover letter, and will be validated when the submission has been received by the Health Authority.
China eCTD Validation Criteria – General Information:
For China eCTD submission technical validations, 149 validation criteria will be applied to the submission, and these validation criteria have been divided into 6 categories – Basic Identification, File/Folder, ICH Backbone File, Regional Administrative Information, Study Tagging File (STF), and PDF Analysis.
If there is an error in the validation report, the submission may not be accepted by the HA. If a warning exists in the validation report, it is recommended to fix the warning before dispatching it for submission to HA. Otherwise, the sponsor will need to add justification in the cover letter to explain why the warning still exists.