8 things you need to know about eCTDs in China
At the end of 2021, China implemented electronic Common Technical Document (eCTD) submissions to accelerate the review and approval of new pharmaceuticals. eCTDs ultimately benefit pharmaceutical and biotech companies by expediting review times, which means faster approvals and a faster time to market. For the regulatory authorities, eCTDs enable more efficient review processes. Although this is a huge step forward for standardization in the Asia Pacific, there are several important things you need to know before you submit your dossier electronically.
Here are eight things you need to know.