eCTD NEWS
RECENT NEWS
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...
eSubmissions (eCTD) The 1st DADI newsletter has been published on the EMA website The digital application dataset integration (DADI) newsletter, published four times a year, provides pharmaceutical companies and the national competent authorities (NCAs) in the EU...
EMA News and press releases: Global regulators call for international collaboration to integrate real-world evidence into regulatory decision-making
EMA News and press releases: EMA launches pilot project on analysis of raw data from clinical trials Other: Information about the raw data proof-of-concept pilot for industry eSubmissions (eCTD) DADI eAF Portal Guide to Registration now available...
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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...
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...
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 (updated): https://bit.ly/3SvM2Vz Template or form:...
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