Pharmaceutical News and Updates

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 or a MA extension for an orphan-designated medicine. This follows the publication of a new…

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 how medicine should best be used by children. Although evidence-based proof is not disputed for…

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 2013/2014 reorganisation of the Agency, the changes fine-tune the re-engineered organisational model to further improve…

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, with the participation of several HTA bodies that allows developers to receive simultaneous feedback from…

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…