eCTD Validation Criteria Version 2.1 in China: What You Need to Know!
The electronic Common Technical Document (eCTD) is a standard format for submitting pharmaceutical Regulatory material to Regulatory Bodies. Many countries worldwide, including China, have adopted this format.
All New Drug Applications (NDAs) in China must be filed in eCTD format, according to the National Medical Products Administration's (NMPA’s) Center for Drug Evaluation (CDE). The eCTD format was first launched in China in 2013, and since then, it has become the industry standard for Regulatory submissions.