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Support Documentation for M8: ECTD EWG ECTD v4.0 Implementation Package v1.6International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use 1eCTD v4.0 Support DocumentationLegal

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Who needs electronic common technical document?

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What is electronic common technical document?

Electronic Common Technical Document (eCTD) is an electronic submission format used for regulatory submissions to health authorities for pharmaceutical products.

Who is required to file electronic common technical document?

Pharmaceutical companies and drug manufacturers are required to file electronic common technical documents.

How to fill out electronic common technical document?

eCTD is filled out using specialized software that allows for the organization and submission of regulatory information in a standardized format.

What is the purpose of electronic common technical document?

The purpose of eCTD is to streamline the regulatory submission process and facilitate the review of pharmaceutical products by health authorities.

What information must be reported on electronic common technical document?

Information such as drug product data, clinical trial results, manufacturing information, and labeling details must be reported on eCTD.

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