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.
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.
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.