Pharmaceutical News and Updates
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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…
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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…
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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…
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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…
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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…
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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…
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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…
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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…
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New EMA framework to enhance patient interaction
During its 2-day meeting in December, the European Medicines Agency (EMA) Management Board adopted the agency’s work programme and budget for 2015 and a preliminary draft programme for 2016. The priorities for human medicines over…
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New international standard to improve safety of medicines
New EMA guide will help industry and regulatory authorities to implement changes The European Medicines Agency (EMA) has published a guide to support the implementation of a new international standard for the safety monitoring of…