Pharmaceutical News and Updates

We are hiring a business manager

We are looking for a business manager to work up to 3 days a week, from anywhere in the UK on a contract basis. RequirementsSignificant experience in the pharmaceutical services sector (Regulatory Affairs, Pharmacovigilance, Clinical Development) with a track record of winning contracts from the Pharma Industry and Biotech. Ability…

EMA/HTA parallel consultation platform

On 30 June 2017 the EMA and EUnetHTA launched the new EMA/HTA parallel consultation platform. The new guidance replaces the former draft best practice guide as of publication date and has been developed from the experience gained with the SEED project, the best practice on EMA/HTA parallel advice pilot from 2010 and the subsequent public…

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…