The European Medicines Agency (EMA) has revised its guidelines on the implementation of accelerated assessment and conditional marketing authorisation, two key tools in the European legislation to accelerate patients’ access to medicines that address unmet medical needs. Accelerated assessment and conditional marketing authorisation are intended for innovative medicines that target a disease for which no [read more…]
Archive for the ‘Pharmaceutical News’ Category
EMA has started publishing the outcomes of PSURs’ assessment.
The European Medicines Agency (EMA) has started to publish the outcomes of single assessments of periodic safety update reports (PSURs), for active substances contained only in nationally authorised medicines as well as the lists of medicines concerned. This initiative will support the harmonised implementation of safety measures, for both Member States and pharmaceutical companies. When [read more…]
Highlights from the EMA-industry ‘platform meeting’
The purpose of these “centralised platform” meetings is to promote awareness about the changes introduced in the centralised evaluation procedure. Initially these meetings are meant to focus on procedural aspects, and may at a later stage extend in scope to also cover other topics related to the centralised procedure. The latest presentation gave a brief [read more…]
Adaptive Pathways in Clinical Developmet
Scientists are suggesting that scientific and political changes may make adaptive pathways the preferred approach for approving new treatments. “Adaptive pathways should be the preferred approach in the near future to bring new medicines to patients.” A number of scientists – including members of the European Medicines Agency (EMA) and its scientific committees – [read more…]
Clinical trial portal in Europe
The EMA Board has endorsed the functional specifications for a clinical trial portal and database that will be developed by the EMA as part of the implementation of the new EU Clinical Trials Regulation. These specifications were drawn up by the EMA in collaboration with the Member States and the European Commission and have been [read more…]
Revised patient interaction framework
The Management Board has adopted a revised framework for the EMA’s interaction with patients, consumers and their representative organisations. One of the goals is to incorporate patients’ and consumers’ values and preferences in all evaluation activities, to further ensure the safe and rational use of medicines. Consulting with and listening to patients and consumers also [read more…]