eCTD NEWS
RECENT NEWS
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...
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
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...
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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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...
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...
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
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...
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...
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...
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...
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...
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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