China eCTD Technical Standards and Submission Requirements Highlights
Since China joined ICH as a regulatory member in 2017, the NMPA (National Medical Product Administration) has been dedicated in reforming the existing China regulatory policy and guidelines to adapt to ICH guidelines. As one of the key reform initiatives, M8 (eCTD) implementation in China has become a spotlight and working priority for both NMPA and industry. With release of draft China eCTD technical guidelines in 2019, NMPA has been working collaboratively with industry and system vendors and successfully completed the system test by end of 2019. This Webinar aims to provide an overview of China eCTD implementation milestones, technical standards interpretation, and highlight China eCTD specific requirements by comparing with the current eCTD version in US and EU.