Navigating eCTD Submissions in China - Webinar Transcript - James Ma - Celegence

Navigating eCTD Submissions in China – Webinar with James Ma

James Ma is responsible for the development and implementation of information technology strategies to enhance the company’s competitive edge. He leads technology platform design, cross-functional business solution building e.g., regulatory and eCTD submissions, infrastructure set up, as well as information security enhancement.

James has over 20 years of IT experience at global pharmaceutical companies and CROs. His main focus is on application design and software engineering for large projects. He joined dMed from the Pfizer China R&D Center, where he was the function lead of Information Management of Global Product Development Operations Center of Excellence.

eCTD Submissions in China – Webinar Background

With the rapid growth of the Chinese pharmaceutical market, more and more companies from overseas are launching their products in China, while the domestic companies in China continue to expand their product development globally. During interactions with health authorities, CTD and eCTD submissions are widely used all over the world to organize and submit regulatory dossiers in a globally harmonized format. China’s health authority, the National Medical Products Administration (NMPA) has also published drafts for Chinese eCTD requirements, technical specifications, and validation criteria to collect public feedback, which could be implemented in the near future.

All eCTD submissions in China will be unique due to the usage of the local language and their specific regulatory requirements; these are challenges that sponsors planning to submit dossiers must be prepared for. This webinar will introduce the requirements for China eCTD submissions and how to develop strategies to comply with them. During our webinar titled “Navigating eCTD Submissions in China” James Ma, spoke specifically about his perspective on how to navigate eCTD submissions in China and the challenges that sponsors must be prepared for.

Why should you read the transcript/watch this video?

  • To best understand the best practices relating to navigating eCTD submissions in China
  • To learn how the NMPA specific requirements may affect your current product lifecycle management
  • To examine the challenges in preparing for China eCTD submissions
  • To find out how to successfully accomplish a China eCTD submission

A full transcript of James Ma’s presentation is available to download (and to read below) and just press play to watch the clip now. 

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China eCTD Overview

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

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 Requirement - Electronic Seal - Celegence

China eCTD Validation Criteria

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.

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Challenges in eCTD Submissions for China

Challenges in eCTD Submissions for China – Submission Dossier Preparation:

Baseline Submission: The first challenge is for submission dossiers from the baseline submission perspective. For the requirements that are specified in the guidance for the NDA application that need to be transitioned from paper to eCTD, it is recommended to submit the module 1, module 2, and module 3 documents as a baseline submission at the earliest possible date.

Submission Timeline: From the submission timeline perspective, the submission preparation timeline needs to be reevaluated. An additional time window for submission publishing is necessary.

All non-Chinese documents need to be translated, and it may take several months to complete the translations. Once the application has been translated to eCTD format, all follow up submissions will need to be in eCTD format, which includes the query response submissions.

Challenges in eCTD Submissions for China – eCTD Submission Publishing

Submission Navigation: The Chinese documents will need to apply full submission navigation. It will be very time consuming to complete the full navigation for all Chinese documents.

Complicated Technical Requirements: China eCTD submissions include two applicable technical requirements, which include and are not limited to, both node extension and STF. Datasets are required to be submitted in eCTD format as well. Warnings need to be justified in the cover letter. Withdraw submissions and others compare to the previously issued eCTD technical specifications and guidance. Only minor changes are made in the most updated ones.

dMed’s Solution

Now, let me introduce our solution to meet these specific requirements.

MNCs and Local Pharmaceutical Companies in China:

We are currently working with pharmaceutical companies to support their eCTD submission, publishing and dispatch in the US to CDER, or CBER. The eCTD submission publishing activities include document formatting, submission compilation, submission publishing, submission validation, dispatching the submission to regulatory agencies, and receiving the submission acknowledgement. The submission publishing is project-based to assist the internal regulatory affairs team to achieve the submission milestones.

eCTD Submission Support for Pharmaceutical Companies

We are also currently working with pharmaceutical companies to support their future eCTD submission publishing in China. As part of these engagements, we provide the eCTD relevant training, a deep dive for the technical specifications released by regulatory agencies, an impact analysis to the current submission preparation process, and we define new submission publishing processes. Additionally, internal system functional testing, internal pilot submission publishing, global submission publishing process harmonization, training, and other business function lines are covered.

eCTD Submission Support Pharmaceutical Companies - Celegence

eCTD Specialists

For more information on how we can help improve your eCTD, reach out to us at info@celegence.com, contact us online or read more about Celegence’s eCTD publishing services.