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TH ECTD Specification Module 1 and Regional Information Version 0.91, August 2014 About the Food and Drug Administration Thailand Bureau of Drug Control The Bureau of Drug Control has set a vision
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What is the eCTD specification?
The eCTD specification is the Electronic Common Technical Document specification used for submitting regulatory information in electronic format.
Who is required to file the eCTD specification?
Pharmaceutical companies, biotech firms, and other regulated industries are required to file the eCTD specification when submitting regulatory information.
How to fill out the eCTD specification?
The eCTD specification can be filled out using specialized software that helps organize and compile the required documents in the electronic format.
What is the purpose of the eCTD specification?
The purpose of the eCTD specification is to standardize the format for regulatory submissions, making it easier for regulatory agencies to review and approve applications.
What information must be reported on the eCTD specification?
The eCTD specification requires information such as drug product information, clinical trial data, and manufacturing details to be reported in the submission.
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