eCTD Submissions China - James Ma - Webinar Q and A 2022 - Celegence

Navigating eCTD Submissions in China – Webinar Q&A with James Ma

Celegence, a Global Regulatory Affairs Services & Technology company for the Life Sciences Industry, partnered with dMed Biopharmaceutical in September, 2021, to offer a webcast titled “Navigating eCTD Submissions in China”.

If you were not able to attend this webinar, check the online replay where you can view the on-demand version. We are here to help answer any other questions that you may have related to the webinar, or about how Celegence can help improve your eCTD requirements, we are happy to assist. Contact us to find out how we can help!

This post contains the Q&A session from the webinar – giving you the answers to the most common questions that were asked about eCTD Submissions in China.

Q: When will the Chinese Health Authority issue the finalized guidance and start to accept the eCTD submissions? Do we have a timetable for that?

A: Currently, there is no fixed date or timetable scheduled by the Health Authority (HA). The most recent update is the HA official website now includes an eCTD specific column, which summarizes the issued draft guidelines, future eCTD submission workflow, and other related information. Also, the eCTD submission channel could be located in the column, although this function is not available as of this moment, but we can see that the Health Authority has made progress in moving the eCTD submission transition forward. The acceptances we expect to start soon.

Q: How can we find the latest specifications for the other supporting guidelines for the ICH eCTD version that the Chinese eCTD version will follow?

A: The latest version of the eCTD guidance, technical specifications, validation criteria, and other guidelines are located on the China Health Authority’s website, as I previously mentioned there is an eCTD specific column in the official website. You can easily locate the guidelines. Unfortunately, there is only a Chinese version and no English version available from the current information. China eCTD is likely to follow ICH eCTD version 3.2.2 instead of 4.0.

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Q: How do you get the official company seal?

A: You can log on to the China Health Authority’s website on behalf of your legal entity and use old functionalities related to the communications with the Health Authority, submit essential documents, and track the submission review progress. You will also need a third party verified hard token. For an MNC you will need an agent in China to be responsible for the product registration and who can apply for the hard token and company seal.

Q: How do you get the product number and the application number?

A: For US submissions, usually you will need to get the application number by email from the FDA. For China eCTD submission, you can apply for the number online. After logging on to the Health Authority’s website, you will get all related functions in the applicant platform.

eCTD Submissions China - Application Number - Celegence

Q: What kind of pilot testing has the CDE conducted and is any future testing scheduled at this moment?

A: The CDE has conducted 2 rounds of pilot testing based on the issued draft guidance and technical specifications. The companies who participated in the pilot were required to submit the submission ready eCTD to CDE. For companies, they need to go through the process to request product numbers and the application number online, fill out the application form, and get the electronic seal. Additionally they have to publish eCTD submissions and ensure the submission could pass the technical validation. After CDE receives the submission, they also go through their internal process to validate and accept the submission.

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Q: Is there any chance for a local regulatory affairs team member to publish an eCTD submission? And if so, what kind of software would be needed for the eCTD submission?

A: Based on our understanding of China eCTD requirements, we can say that China eCTD follows a very high standard for eCTD submissions. It includes several complicated concepts and life cycle operations. We highly recommend publishing the submission by qualified submission publishers. A publishing system with a China specific submission template is required to publish the submissions. Regarding the validation part, the CDE is planning to provide the validator on the website for everyone to use for free.

Q: What opportunities may the eCTD bring in for manufacturers?

A: After China joined the ICH, there were more collaborations in the pharmaceutical industry. Local vendors in China have already established the capability to support translation document submissions, ready check publishing, system hosting, and submission publishing. With the implementation of eCTD, it helps to improve the submission dossier quality and enhance the product life cycle management.

James Ma - dMed Executive Director - Celegence Webinar

Q: In your perspective, how should you prepare for the implementation of eCTD?

A: It is very important to most companies. For both local pharmaceutical companies and MNCs, the strategy to establish the internal publishing team or outsourcing the publishing workload, needs to be developed. From a system perspective, either the system would be hosted by a vendor or in an internal environment. For MNCs or local actors with licensing products, getting a reliable translation vendor as a partner and identifying the parties to be responsible for the document level to be submission ready is extremely important. Thank you.

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