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eCTD NEWS

RECENT NEWS

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eCTD Industry Update (3rd January 2023)

EMA Newsletter: DADI newsletter - Issue 2 Newsletter: Clinical Trials Highlights - December 2022 (updated) eSUBMISSIONS (eCTD) Updated draft eCTD v4.0 implementation timeline for EU now available - An updated draft timeline for the implementation of eCTD v4.0...
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eCTD Industry Update (21st December 2022)

EMA Regulatory and procedural guideline: IRIS guide to registration and RPIs (updated) Human variations electronic application forms public training , Online, 10:00 - 11:30 Amsterdam time (CET), from 15/12/2022 to 15/12/2022
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eCTD Industry Update (13th December 2022)

EMA Human variations electronic application forms Q&A clinics – session 5 , Online, 14:30 - 15:00 Amsterdam time (CET), from 19/12/2022 to 19/12/2022 Regulatory and procedural guideline: EudraVigilance registration documents (updated) Human Variations electronic application...
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eCTD Industry Update (2nd November 2022)

eSubmission: - eSubmission Gateway XML delivery file update for Raw Data submissions: An updated version of the eSubmission Gateway XML delivery file user interface is now available. This update has introduced a small change to...
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eCTD Industry Update (10th January 2023)

EMA European Medicines Agency post-authorisation procedural advice for users of the Centralised Procedure Clean Version / Tracked Version (updated) European Medicines Agency Pre-authorisation guidance - Clean Version / Tracked Version (updated) Regulatory and procedural guideline: Validation checklist for Type II...
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eCTD Industry Update (3rd January 2023)

EMA Newsletter: DADI newsletter - Issue 2 Newsletter: Clinical Trials Highlights - December 2022 (updated) eSUBMISSIONS (eCTD) Updated draft eCTD v4.0 implementation timeline for EU now available - An updated draft timeline for the implementation of eCTD v4.0 in the EU is now...
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eCTD Industry Update (21st December 2022)

EMA Regulatory and procedural guideline: IRIS guide to registration and RPIs (updated) Human variations electronic application forms public training , Online, 10:00 - 11:30 Amsterdam time (CET), from 15/12/2022 to 15/12/2022
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BLOGS

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What is eCTD metadata?

An electronic Common Technical Document, or eCTD as it is more commonly referred to, offers a standard format for submitting regulatory information to health authorities. As a result, it is an integral part of how organisations within the pharmaceutical sector...
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Meeting table

How to get ready for eCTD submission

eCTD (electronic Common Technical Document) submission is an extremely complex process, which means it helps to be prepared. When submitting regulatory information such as applications, reports and supplements in this standard format, the documents and cross-links required have to be...
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What is an eCTD viewer

What is an eCTD viewer?

As the standard format of submitting regulatory information to health authorities, an eCTD or electronic common technical document is essential for all organisations within the pharmaceutical industry. Used worldwide for the submission of applications, supplements and reports, an eCTD ensures...
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streamline your esubmission with ONIX word template

How to streamline your eSubmission with ONIX predefined eCTD Word templates

Creating documents for an eCTD application is time consuming and involves numerous authors, resulting in document formatting inconsistencies and a lengthy review and approval process. The ONIX eCTD Microsoft Word templates streamline the process by providing a standard structure. What...
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what is needed for an investigational new drug application IND

What is needed for an Investigational New Drug Application (IND)?

To get your drug into clinical trials in the United States, you first need to obtain Investigational New Drug (IND) approval from the FDA (Food and Drug Administration). This may sound simple, but even getting to the stage of applying...
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portable document format specifications ectd submissions

What are the portable document format specifications for eCTD submissions?

One of the eCTD publishing services we offer here at ONIX is PDF formatting. This is an essential part of eCTD submission. We must ensure we follow the industry guidance on PDF (portable document format specifications) to meet the maximum...
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