EMA, together with the eCTD v4.0 EU Subject Matter Experts group, is planning a Vendor Workshop in Q1 2024. To assess the availability, interest and further topics for discussion, the Vendors are invited to complete the eCTD v4.0 Vendor Workshop survey by end of day 15 February 2024.
Added in January 22 January NEW - 23-25 January 2024 CMDh agenda
Meeting 23-25 January: Agenda
Yimmugo Date of publication: 20/12/2023
This is the 'Recently Published' page for the Human Medicines section
Member: Vacant National Institute of Pharmacy and Nutrition Zrínyi U. 3 H-1051 BUDAPEST
Updated v1.26.0.0 Human MAA eAF is now available on the eAF website. The form is ready for immediate use. The change implemented in this version is a minor bug fix (related to Annex 5.19).
In light of an ongoing application study at the European Medicines Agency, we are gathering feedback on the eSubmission website.
In light of an ongoing application study at the European Medicines Agency, we are gathering feedback on the PSUR Repository.