eCTD NEWS
RECENT NEWS
EMA PRIME: priority medicines (updated) Other: European Medicines Agency guidance for applicants seeking access to PRIME scheme (updated) Referrals document: Nitrosamines EMEA-H-A5(3)-1490 - Questions and answers for marketing authorisation holders / applicants on the CHMP Opinion for the Article...
EMA Regulatory and procedural guideline:Procedural advice on publication of information on withdrawals of applications related to the marketing authorisation of human medicinal products (updated) eSubmissions (eCTD) PSUR Repository (NCA UI) Go-live 3rd July 2023 We are...
EMA Clinical Trials Information System (CTIS): Information day , Online, 13:30- 17:30 Amsterdam time (CET), from 17/10/2023 to 17/10/2023 EudraVigilance and Signal Management information day , European Medicines Agency, Amsterdam, the Netherlands, 09:30-17:00 CET, from 21/11/2023 to...
EMA Paediatric investigation plans: Templates, forms and submission dates (updated) Regulatory and procedural guideline: Guidance on paediatric submissions (updated) Clinical Trials Information System: training and support (updated) Human variations electronic Application Form (eAF) & Product...
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FDA 17/07/2023 Medical Device - Qualification of Medical Device Development Tools 19/07/2023 0356h Forms
EMA 13/07/2023 Clinical Trials Information System (CTIS): Information day , Online, 13:30- 17:30 Amsterdam time (CET), from 17/10/2023 to 17/10/2023 (updated) 12/07/2023 Other: Guide to information on human medicines evaluated by European Medicines Agency: what the Agency publishes and when...
EMA PRIME: priority medicines (updated) Other: European Medicines Agency guidance for applicants seeking access to PRIME scheme (updated) Referrals document: Nitrosamines EMEA-H-A5(3)-1490 - Questions and answers for marketing authorisation holders / applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No...
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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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