Best Practice Guide - Measures to Improve Predictability of Submissions
The HMA/EMA joint Task Force on Adherence to Time tables has created a joint Best Practice Guide with Industry associations and HMA/EMA.
EU eSubmission Roadmap
An updated version of the EU eSubmission Roadmap v.2.0 has been approved by EUTMB and endorsed by the HMA. The Roadmap has been updated to reflect achieved milestones and to include new and amended timelines for implementation of various telematics systems/standards. A visual representation of the milestones is available here and information on the main changes can be found in the release notes.
Futher information is available on the EMA website eSubmissions section.
HMA Work Programme 2014
This work programme sets out the preliminary draft for all HMA Working Groups and Taskforces for 2014. Specific work areas have been identified from themes taken from the HMA Strategy for 2011-2015. The key topics which are addressed are; safeguarding public health and animal health, supporting innovation and further improving operational efficiency of medicines authorisation.
The HMA Working Group of Communication Professionals (WGCP) have prepared the leaflet (designed by the Press & Communication Office, AIFA) to inform about the HMA mission statement, main activities and give other useful information regarding the HMA work within the European Regulatory Network.