Lorenz Blog

Based on the latest requirements of the “Measures for the Administration of Drug Registration”, the “M4 Administration documents and drug information” and other relevant supporting documents, the previously released “eCTD submission guideline (draft),” “eCTD technical specification (draft)” and “eCTD validation criteria (draft)” have been modified, and now CDE is soliciting opinions from the public again. Comments and suggestions can be sent to CDE by email before October 21, 2020 as required by the feedback template.

The main updates are as follows:

1. Update in Module 1

Modified Module 1 schema with new elements and updated validation criteria is described in “eCTD submission guideline,” “eCTD technical specification” and “eCTD validation criteria.”

2. Adjustment of the type of registration behaviors

(1) For clinical trial applications, “new indications” has been changed to “new indications and drug combination,” “safety report” has been changed to “safety report during research and development,” and the type of “annual pharmaceutical report” has been deleted.

(2) For new drug applications, two types of registration have been added: “filing” and “reporting.”

(3) For generic drug applications, three types of registration behavior have been added: “record,” “report” and “new indications.”

3. Requirement to use node extensions

For biological products, the “eCTD technical specification” introduces a higher granularity in section 3.2.R. Node extensions will become mandatory.

4. Submission requirements for clinical data sets

In “eCTD validation criteria” the use of STF file labels for clinical trial database-related documents has been added, validation items for database files and data description files have been added.

5. Other adjustments

Compared to the released drafts in March and September 2019, these released drafts of “eCTD submission guideline,” “eCTD technical specification” and “eCTD validation criteria” have also had some adjustments and corrections to the description. These changes are according to the previously collected feedback, to reduce misunderstandings and create clear and definite eCTD submission data requirements.

6. Clarification

As the change to the submission data requirements has not yet officially been released, in the eCTD validation criteria the integrity of the “supplementary application” registration behavior type and other data have not been verified. After the issuance of the relevant regulations, the eCTD technical documents will be adjusted according to the specific requirements.