Pharmaceutical News and Updates
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Update to Orphan Product MAA variations
On November 18, 2016, EMA published an update to the post-authorisation guidance on MA extensions and type II variations to include further details on the information companies need to provide when submitting a Type II variation…
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The public consultation on Europe’s Paediatric Regulation
The Paediatric Regulation (Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products) was adopted in 2007 to address a serious gap in knowledge on…
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Reorganisational Change at EMA
The European Medicines Agency (EMA) has announced some organisational adjustments and important strategic amendments of its corporate management structure that will result in a leaner, more streamlined architecture and improved administrative support. Building on the…
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EMA publishes report on parallel Scientific Advice
EMA published a report on the pilot on its parallel regulatory-health technology assessment scientific advice with a Best Practice Guide. Background: Since 2010, the EMA has initiated a pilot project of parallel HTA-regulatory scientific advice,…
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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…
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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…