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.
The most recent eCTD update in China came in June 2021, when the CDE announced they would adopt a new version of the eCTD validation criteria. The revised version, "eCTD validation criteria version 2.1," came into effect on July 01, 2021.
The new eCTD validation criteria have several changes and improvements to the previous version, including:
- New Validation Rules: The updated e-CTD validation criteria include several new rules to guarantee that submitted documents are accurate and complete.
- Improved Validation Performance: The new version contains validation process improvements that will make it faster and more efficient.
- Simplified Submission Process: The new version features a simplified submission process, making it easier for applicants to send Regulatory information.
- Enhanced Security: The new version contains an enhanced security feature to safeguard the submitted information's confidentiality and integrity.
It should be noted that the new eCTD validation criteria version 2.1 applies only to NDAs filed after July 1, 2021. Prior to this date, NDAs will be subjected to the prior version of the eCTD validation criteria.
The eCTD format has become the industry standard for Regulatory submissions in China. The most recent change to the eCTD validation standards will further improve the submission process's efficiency and accuracy.
Pharmaceutical companies intending to submit NDAs in China should familiarize themselves with the most recent requirements and guidelines to avoid delays or issues in the Regulatory approval process.
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