2021 年 7 月 28 日

Looking Toward eCTD in China: What You Need to Know

Since China joined the ICH in 2017, the NMPA is undertaking tremendous efforts to gradually transform its pharmaceutical regulatory authorities, industry, and research institutions to implement the international coalition’s technical standards and guidelines.

As we await the final specifications for the NMPA’s move to eCTD, organizations need to ensure they scale up their local teams and grow their knowledge so they will be ready to comply.

So, what does eCTD readiness look like for submissions in China?

Calyx Christina Guo

“eCTD submissions are a fundamental change to the way China publishing teams work today.”

– Christina Guo, Solution Consultant, Calyx

Overview

A single eCTD business process goes through a number of steps (figure 1) Understanding each of these will position your organization for success as you prepare for eCTD in China.

A Single eCTD Business Process

1. Authoring

The purpose of granulating documents is to manage the appropriate document suitable for the structure of eCTD.

CDE recommends that all MAHs draft submission documents according to ICH CTD guidance and have provided extensive guidance as a reference, including suggestions to generate your own submission files.

It is time-consuming to draft submission files and adjust the styles of files each time. Utilization of templates (Figure 2) and style guidance upfront improves efficiencies for your day-to-day work. Authors can then modify only the associated content and change the styles when necessary for submission files. ICH M4 guidance and the regional specifications should be followed.
What you have done prior to this step is the preparation activities. Now it is time for drafting submission documents.

The following items might be considered when processing.

 

  • Has a Table of Contents been created for documents exceeding 5 pages?
  • Have the Internal Links been created for the keywords (e.g. Table/Figure/Append/Section…)?
  • Are the Headings appropriately set for the phrases you would like and do they display correctly as bookmarks in the PDF version?

Non-Chinese documents should be translated into Chinese prior to inclusion in the submission dossier. The effort of these translations and the time required must be included as part of the submission preparation and taken into consideration when evaluating the workload.

 

So, when is this necessary?

 

If you are reusing documentation that has been used for applications in another region (often module 2-5), these documents need to be translated into Chinese. The original non-Chinese files must be submitted together with the translations.

 

Any documents included as references, which are important for agency review, must also be translated into Chinese.

2. Formatting

Having authored the documentation utilizing the templates, a final check of the formatting is required.

 

Why conduct further checks? The word files are produced by authors or translators. These subject matter experts focus on the content, it is up to the publishers to address any formatting anomalies.

 

Taking the time to double-check the formatting and rectify any issues (e.g. the incorrect style is used, resulting in a bookmark error, an invalid interlink, etc.) ensures that you will not receive any validation errors following submission to NMPA which could delay authorization.

Convert the Word documents into PDF and assign the properties of the PDF to ensure compliance with the specification of validation criteria for each region. This is critical to avoiding error messages upon submission to the agency, including not only the individual document properties but also the PDF version used.

3. Publishing eCTD

At the beginning of the first eCTD project, the primary consideration is how to select the right vendor of a publishing solution which can manage eCTD. As you do so, consider the lead time for the procurement and selection processes, as well as the set-up and implementation of the solution.

 

A well implemented eCTD software enables you to maintain a complete overview of evolving product approvals and changes; to know which product / safety information / indications are approved for each country and where and when the resources will be required to prepare those submissions, as well as to monitor the KPIs.

 

Selecting a vendor who will monitor the health authorities to ensure that regulatory updates to dossier requirements are reflected in their tools will enable you to compile compliant submissions and avoid unnecessary delays.

 

Calyx RIM’s publishing solution provides comprehensive and scalable submission publishing that is suitable for operations of all sizes and produces output that is compliant with all current regulatory agency requirements. It has easy-to-use submission assembly controls with components designed specifically for the capture and management of eCTD metadata. Submission assembly templates are provided and maintained by Calyx for the eCTD and non-eCTD formats and can be modified to meet a client’s specific requirements.

 

Following vendor selection, your team will be trained on the publishing solution and processes will be defined and rolled out. Workshops with your subject matter experts will ensure that your experts are able to adopt best practices and to benefit from optimal efficiencies with your new solution.
You are now ready to produce compliant eCTD dossiers.

 

A well-implemented system enables you to reuse the structure / documents of other applications into the current application to increase efficiency for your publishing teams.

 

Calyx RIM’s submission wizards streamline the creation of initial submissions and lifecycle sequences and support the concept of planned submissions, preventing lifecycle operation conflicts on submitted content.

 

Supporting iterative publishing of individual sections of the assembly as they are completed ensures that all publishing-created XML files (index.xml, regional XML and study tagging files) are rebuilt to include the latest information, such as updated checksum values for content published. During publishing all the necessary components for a compliant submission, including the required ICH and regional XML files, correctly named leaf files, folder structures, and any requisite navigation aids are created.

 

 

4. Validator eCTD

Verify compliance by validating the final eCTD dossier with the eCTD tool.  Any issues captured must be addressed prior to the next step.

 

Validator tools are developed in accordance with the validation specification criteria of each region. Features help to validate eCTD submissions created by any software application through a variety of validations, confirming that the submission is complete and accurate and allowing for ICH and regional requirements and specifications prior to sending it to the agency.

 

This is necessary to ensure the final eCTD dossier will pass the technical verification of the agency and be received ready for their review and authorization.

5. QC eCTD

Why does the final eCTD dossier entail a double QC?

The Validator tool checks that the links are not corrupted and have a target. With this manual QC, publishers must check that the links / bookmarks make it easy for the reviewer to navigate the submission. Some agencies may also have requirements on what should be bookmarked / linked, which are not part of the validation criteria.

6. Deliver eCTD to HA

You are now ready to submit the eCTD dossier to HA.

 

With the move to eCTD, the NMPA will also change the way they accept submissions. CD and DVD formats will no longer be required and instead the use of the electronic submission gateway will be utilized to accelerate the submission delivery process.

Conclusion

eCTD submissions are a fundamental change to the way China publishing teams work today. As you look toward regulatory compliance, start optimizing your processes to stay on top of evolving regulations.

There is no need to wait for the final specification. Starting now will pave your way to success.


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