Pharmaceutical News and Updates

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…

Latest EMA-HTA meeting minutes

The EMA has published the minutes of its face-to-face meeting with the EUnetHTA (European Network for Health Technology Assessment) which was held on 8 May 2015. There were in-depth discussions on various items during this meeting including: Update on Medicines Adaptive Pathways to Patients’ (MAPPs) and Adaptive Pathways (AP) Pilots:…

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…

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)…

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…

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…