From January 2024, EMA is launching a proof-of-concept study to evaluate the added value of using SEND data in the evaluation of new Marketing Authorisation Applications. Applicants are encouraged to submit their SEND data packages, in addition to the eCDT format, as part of their MAA submission. The SEND package must be provided outside the [...]
Member: Petra Gubová Alternate: Kristína Ráczová State Institute for Drug Control Kvetná 11 SK-825 08 BRATISLAVA 26
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.
Yimmugo Date of publication: 20/12/2023
Added in January 22 January NEW - 23-25 January 2024 CMDh agenda
Meeting 23-25 January: Agenda
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).