Regulatory Open Forum

Dear colleagues,

I'm currently looking into the status of international countries and eCTD.
I know over the last years already a number of countries made eCTD the mandatory dossier format.
But I would live to see an overview of who already implemented it, who is on the way and how about eCTD 4.0.

Any suggestions where to find this information is welocme.

Best regards,

Jens

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Jens Pantke
Moderna Therapeutics, Inc. - ENTERPRISE
Cambridge MA
United States
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Dear Jens,
I advise contacting a company such as Lorenz or Extedo that sells eCTD compiling software.  They are likely knowledgeable about which countries implemented eCTD.

Here is a link to the FDA's website regarding eCTD 4.0.
https://www.fda.gov/drugs/electronic-regulatory-submission-and-review/electronic-common-technical-document-ectd-v40

Kind Regards,
Sarah

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Sarah Green
Regulatory Affairs Specialist
Knoxville TN
United States
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Original Message:
Sent: 16-May-2021 09:25
From: Jens Pantke
Subject: International eCTD status

Dear colleagues,

I'm currently looking into the status of international countries and eCTD.
I know over the last years already a number of countries made eCTD the mandatory dossier format.
But I would live to see an overview of who already implemented it, who is on the way and how about eCTD 4.0.

Any suggestions where to find this information is welocme.

Best regards,

Jens

------------------------------
Jens Pantke
Moderna Therapeutics, Inc. - ENTERPRISE
Cambridge MA
United States
------------------------------