eCTD NEWS
RECENT NEWS
DADI Human Variations eAF User Acceptance Testing (UAT) – Call for Volunteers In the context of the digitalisation of the Variations Application Form for Human Medicinal Products, the EMA is pleased to invite applicants to...
EMA: Regulatory and procedural guideline: Procedural guidance for variant strain(s) update to vaccines for protection against human coronavirus (updated) Regulatory and procedural guideline: Checklist for annual updates for parallel distribution: guidance for industry (updated): Regulatory and procedural...
ICH: ICH electronic Common Technical Document – eCTD v4.0 CMDh: National recommendations for request to act as RMS (June 2022) MHRA: Guidance on handling of Decentralised and Mutual Recognition Procedures which are approved or pending –...
EMA: Regulatory and procedural guideline: Compilation of quality review of documents (QRD) on stylistic matters in product information (updated) - https://bit.ly/3xNMerv Submitting annual reports on medicine development (updated) - https://bit.ly/3MU0GSR Changing the name or address of a...
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CMDh New - Template for Applicants to Prepare Similarity Report Update - Applicant's response document in Mutual Recognition and Decentralised Procedures for Marketing Authorisation Applications (Clean / Tracked Version) Update - RMS validation checklist for human medicinal products in DCP Update - Request for MRP/RUP / Update assessment report Update - CMDh Best...
EMA DADI PDF electronic application forms (eAF) training webinar, Online, 11:00 - 12:30 Amsterdam time (CEST), from 02/09/2022 to 02/09/2022 (updated) Organisation Management System (OMS) Trouble Shooting Session for CTIS users - September 2022, from 22/09/2022 to 22/09/2022 (updated) Clinical Trials Information System...
EMA EMA Account Management training webinar Quarterly system demo - Q3 2022 Regulatory and procedural guideline: IRIS guide to registration and RPIs (updated)
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