eCTD NEWS
RECENT NEWS
EMA Webinar on submissions of parallel distribution notifications for centrally authorised products (CAPs) FDA Addition of the new validation error code 1738. Update to the 4.4 problems for error code 1735. Update the description and...
IRISS IRIS guide for applicants - How to create and submit scientific applications, for industry and individual applicants (updated) EMA Digital application dataset integration (DADI) and Product Management Service (PMS) webinar - Variations form for human medicinal...
EMA 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 726/2004 referral on nitrosamine impurities in human medicinal products (updated) Regulatory...
Tired of corrupt documents? Want a bit more automation in your authoring? Maybe it's time to use a template toolbar created by experts! The team of consultants at ONIX have created a solution that can...
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EMA IRIS guide for applicants - How to create and submit scientific applications for industry and individual applicants (updated) CMDh Update: Step 2 - No nitrosamine detected response template Update: EMA/CMDh explanatory notes on Variation Application Form - Human medicinal products only (Clean Version /...
FDA Specifications for File Format Types Using eCTD Specifications
EMA Newsletter: News bulletin for small and medium-sized enterprises - Issue 56 eSubmissions (eCTD) Questions and Answers document from the public webinar “DADI Q&A Webinar - Variations form for Human Medicinal Products Go-live” held on 12th July 2022 The Q&A document from the...
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