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eCTD NEWS

RECENT NEWS

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eCTD Industry Update (17th October 2022)

EMA Regulatory and procedural guideline: European Medicines Agency guidance for applicants seeking scientific advice and protocol assistance (updated) Instructor's guide: How to create, submit and withdraw a Clinical Trial Application - CTIS Training Programme - Module 10 (updated)...
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eCTD Industry Update (4th October 2022)

EMA: Orphans: Regulatory and procedural guidance and forms (updated): https://bit.ly/3mNjzfG Product-information templates - Human (updated): https://bit.ly/3SQI61z Template or form: QRD product-information template version 10.3 (updated): https://bit.ly/3SyQu61 Template or form: QRD product-information annotated template (English) version 10.3 - highlighted...
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eCTD Industry Update (28th September 2022)

CMDh New - Template for Applicants to Prepare Similarity Report Update - Applicant's response document in Mutual Recognition and Decentralised Procedures for Marketing Authorisation Applications (Clean / Tracked Version) Update - RMS validation checklist for human medicinal products in DCP Update - Request for MRP/RUP...
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eCTD Industry Update (20th September 2022)

EMA DADI PDF electronic application forms (eAF) training webinar, Online, 11:00 - 12:30 Amsterdam time (CEST), from 02/09/2022 to 02/09/2022 (updated) Organisation Management System (OMS) Trouble Shooting Session for CTIS users - September 2022, from 22/09/2022 to...
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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 forms public training , Online,...
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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 the delivery file (addition of...
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eCTD Industry Update (17th October 2022)

EMA Regulatory and procedural guideline: European Medicines Agency guidance for applicants seeking scientific advice and protocol assistance (updated) Instructor's guide: How to create, submit and withdraw a Clinical Trial Application - CTIS Training Programme - Module 10 (updated) European Medicines Agency practical guidance...
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BLOGS

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what is eCTD validations criteria cropped

What is eCTD validation criteria?

The eCTD validation criteria are a set of standards that must be met in order for an eCTD submission to be considered valid. These criteria are designed to ensure that the submission is complete and accurate and that all required...
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what is an ectd gateway

What is an eCTD gateway?

In previous posts, we have discussed what eCTD is and what an eCTD submission is. This post will look at electronic submission gateways and how they can be used to submit regulatory documents. Electronic submission gateways have been implemented to...
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the benefits of eCTD

The Benefits of eCTD

The eCTD is comprised of 5 modules, each of which has its own requirements in terms of documents and content. The benefits of eCTD include: eCTD has become a mandatory format requirement for many regulatory health authorities; Europe, the US,...
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submit

What is an eCTD submission?

All life science companies require approval from Regulatory Health Authorities to place their human, medical device, or veterinary medicinal products on the market. For approval to be granted, the drug application data needs to be submitted in an electronic format,...
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regulatory affairs

What is eCTD in Regulatory Affairs?

All life science companies require approval from Regulatory Health Authorities to place their human, medical device or veterinary medicinal products on the market. Electronic common technical document (eCTD) is a mandatory format for submissions to Regulatory Health Authorities, which is...
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