eCTD NEWS
RECENT NEWS
EMA PRIME: priority medicines (updated) MHRA Register medical devices to place on the market - 27 March 2023 – Guidance
FDA FDA Forms Updated - www.fda.gov/about-fda/reports-manuals-forms/forms
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...
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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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...
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)
EMA PRIME: priority medicines (updated) MHRA Register medical devices to place on the market - 27 March 2023 – Guidance
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BLOGS
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...
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...
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,...
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,...
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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