The Belgian Federal Agency for Medicines and Health Products (FAGG) has released an updated version 2.11 of the national eSubmission Guideline applicable for electronic...[more]
The Co-ordination Group for Mutual Recognition and Decentralized Procedures - Human (CMDh) has released an updated revision 3 of the "Best Practice Guide on the Use of the...[more]
The Spanish Medicines Agency AEMPS (Agencia Española de Medicamentos y Productos Sanitarios) has releases and updated version 2.1 of their national eSubmission guidance...[more]
The U.S. Food and Drug Administration (FDA) has published the draft "eCTD Backbone Files Specification for Module 1 Version 2.0" together with the updated...[more]
The Belgian Federal Agency for Medicines and Health Products (FAGG) has revoke the previously released version v.2.9.b (see our related News Article from September) of the...[more]
Health Canada has further increased it's scope of submissions that are accepted in eCTD-only format. In addition to the announcement in May this year (see our previous News...[more]
Update! Please note that the information below is outdated. Meanwhile, the version v.2.9.b of the NeeS checker has been revoked by the FAGG. See our related News Article from...[more]
