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eCTD NEWS

RECENT NEWS

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eCTD Industry Update (5th April 2023)

EMA PRIME: priority medicines (updated) MHRA Register medical devices to place on the market - 27 March 2023 – Guidance
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eCTD Industry Update (27th March 2023)

FDA FDA Forms Updated - www.fda.gov/about-fda/reports-manuals-forms/forms
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eCTD Industry Update (17th March 2023)

EMA: Newsletter: CTIS newsflash – 17 March 2023 eSubmissions (eCTD): 17-03-2023 Common Repository Go-Live on 20th of March 2023 (relevant for NCAs only) We are pleased to inform you that the next version of the...
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eCTD Industry Update (13th March 2023)

EMA Newsletter: CTIS newsflash - 10 March 2023 Other: European Medicines Agency’s data protection notice for the European Union (EU) Metadata Catalogue Other: Orphan medicines figures 2000-2022 (updated) Report: Annual report on the use of the special contribution for orphan...
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eCTD Industry Update (18th April 2023)

EMA Regulatory and procedural guideline: Guide for rapporteurs and coordinators on the multinational assessment teams (updated) Template or form: Template for response to list of questions/list of outstanding issues: Quality / Non-clinical / Clinical Clinical Trials Information System (CTIS): Walk-in clinic - March...
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eCTD Industry Update (11th April 2023)

EMA EMA GCP IWG points to consider regarding the management of ongoing clinical trials impacted by political conflicts, natural disasters or other major disruptions News and press releases: New features further strengthen Priority Medicines scheme (PRIME) Medical devices (updated)
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eCTD Industry Update (5th April 2023)

EMA PRIME: priority medicines (updated) MHRA Register medical devices to place on the market - 27 March 2023 – 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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