In recent months, China’s Center for Drug Evaluation (CDE) has released draft information regarding the future of electronic common technical document (eCTD) submissions in China. While things may change between this draft information and the final specification, understanding this draft is critical for all companies that want to conduct clinical research in the country.

For example, China has adopted the current technical specifications of International Conference of Harmonisation (ICH) specification 3.2.2. The specifications refer to the FDA’s eCTD submission process.  Therefore, China’s requirements are more reflective of the FDA’s eCTD specifications than to EMA’s eCTD process. Specifically, clinical trial datasets are required as well as the use of study tagging files (STF). Node extensions are not allowed.

Here are a few other insights gleaned from China’s draft information:

  • Module 2 to Module 5 will follow the format requirements of ICH eCTD
  • The biggest hurdle for non-Chinese eCTD submitters is that documents must be provided in Chinese with English versions as reference. eCTD leaf titles also must be in Chinese.
  • The first sequence will be 0000, which deviates from the US requirement of 0001 for the current US 3.3 regional DTD.
  • China intends to provide a link to its official CDE website for eCTD validation, which will be free of charge.
  • Current CDE validation specifications only require error and warning information and no prompt information. Validation of both English and Chinese documents is still to be resolved.
  • CD/DVD submission will be required at first but Gateway submissions will follow at some point.

The release of the final eCTD specification, scope of submissions impacted, transition period, and final implementation date are still to be determined. However, if recent activity is an indicator, we can expect that some of these remaining items will be released in the next year or two.

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