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ICH ECTD Specification Change Control V1.9INTERNATIONAL COUNCIL FOR Harmonization OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN Change Control Process for the ECTD Version
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How to fill out ich ectd specification change

01
Step 1: Go to the ICH website and download the eCTD specification change document.
02
Step 2: Familiarize yourself with the changes mentioned in the document.
03
Step 3: Review your existing eCTD submission to identify areas that need to be updated as per the specification change.
04
Step 4: Create a checklist of all the required changes.
05
Step 5: Update the relevant sections of your eCTD submission based on the checklist.
06
Step 6: Perform a thorough quality check to ensure all the changes have been correctly implemented.
07
Step 7: Once satisfied, generate the revised eCTD submission package.
08
Step 8: Submit the revised package to the appropriate regulatory authority.

Who needs ich ectd specification change?

01
Pharmaceutical companies
02
Biotechnology companies
03
Contract research organizations (CROs)
04
Regulatory affairs professionals
05
Clinical research organizations (CROs)
06
Regulatory authorities
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ICH eCTD specification change refers to any updates or modifications made to the International Council for Harmonisation's electronic Common Technical Document (eCTD) standard.
Any pharmaceutical company or drug manufacturer that submits regulatory documents using the eCTD format is required to comply with the ICH eCTD specification change.
To fill out the ICH eCTD specification change, companies must update their eCTD software and templates according to the latest ICH guidelines.
The purpose of the ICH eCTD specification change is to ensure consistency and standardization in the format of regulatory submissions, making it easier for regulatory authorities to review and process the documents.
The ICH eCTD specification change typically includes updates to the technical requirements, file structures, and metadata fields used in the eCTD submissions.
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