Pharmaceutical News and Updates

ICH Readies new guidance

The Assembly finalised its rules of procedure, which reflect the new emphasis on clearer governance, transparency and openness in the operation of the reformed ICH, and will be published shortly. Key advances for public health ICH aims to improve health through harmonisation of global regulatory requirements. Some of the key…

EMA Management Board: highlights of October 2015 meeting

The Management Board heard an update on the European Medicines Agency’s (EMA) activities in the first half of 2015. Overall, the mid-year report for 2015 shows that the Agency’s operations were largely in line with its forecast. There was a notable increase in the Agency’s activities supporting innovation and development…

Fast-track drug approval for unmet medical needs in Europe

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…

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…