Blog
RSS FeedPosted by Michael Wonder on 07 Feb 2018
Management Board started building approval process of EMA premises in Amsterdam
7 February 2018 - Members discussed temporary and permanent premises. ...
Posted by Michael Wonder on 06 Feb 2018
General Court confirms EMA approach to transparency
6 February 2018 - Three rulings clarify the scope of commercial confidentiality with regard to authorised medicines ...
Posted by Michael Wonder on 06 Feb 2018
GW Pharmaceuticals announces the EMA accepts Epidiolex (cannabidiol) marketing authorisation application for review
5 February 2018 - Application seeking regulatory approval of Epidiolex for seizures associated with Lennox-Gastaut syndrome and Dravet syndrome. ...
Posted by Michael Wonder on 04 Feb 2018
Is Europe ready for a single health technology assessment?
2 February 2018 - After years of preparation, the EU unveiled plans for greater health technology assessment harmonisation this week ...
Posted by Michael Wonder on 03 Feb 2018
European Medicines Agency accepts fremanezumab marketing authorisation application
2 February 2018 - Teva seeking EU regulatory approval for anti-CGRP therapy for the prevention of migraine. ...
Posted by Michael Wonder on 03 Feb 2018
Strengthened guidance on follow-up and risk management for ATMP developers
2 February 2018 - Guideline to streamline procedures and better address the specific requirements of ATMP developers published for consultation ...
Posted by Michael Wonder on 01 Feb 2018
EU proposes joint studies to speed acceptance of new medicine
31 January 2018 - The European Commission proposed on Wednesday joint clinical assessments to determine whether approved new drugs and ...
Posted by Michael Wonder on 01 Feb 2018
Post-Brexit destination of EU medicines regulator thrown into doubt as Italy launches appeal
1 February 2018 - The final destination of the EMA after Brexit was on Wednesday thrown back into question after ...
Posted by Michael Wonder on 01 Feb 2018
Sanofi, DNDi seek European Medicines Agency review for sleeping sickness treatment
1 February 2018 - Dossier will be reviewed under the Article 58 procedure, which is intended for medicines that will be ...
Posted by Michael Wonder on 01 Feb 2018
Evaluation of advanced therapy medicines
1 February 2018 - Updated procedural advice clarifies regulatory process for advanced therapy medicinal products ...
Posted by Michael Wonder on 31 Jan 2018
How to better apply the paediatric legislation to boost development of medicines for children
31 January 2018 - EMA and European Commission invite stakeholders to register for joint workshop and support development of an ...
Posted by Michael Wonder on 30 Jan 2018
The impact of parallel regulatory-HTA scientific advice on clinical development. Assessing the uptake of regulatory and HTA recommendations.
30 January 2018 - The “Parallel regulatory-HTA scientific advice” procedure allows manufacturers to receive simultaneous feedback from both EU regulators and ...
Posted by Michael Wonder on 29 Jan 2018
Brexit Alliance calls for Brexit deal on medicines regulation
29 January 2018 - The Brexit Health Alliance is again warning that medicines supply in the UK is in danger ...
Posted by Michael Wonder on 29 Jan 2018
Statement by EMA Executive Director Guido Rasi in The Hague
29 January 2018 - EMA relocation project – press conference with Dutch authorities. ...
Posted by Michael Wonder on 27 Jan 2018
Repros announces negative opinion from the EMA for enclomiphene
26 January 2018 - Repros Therapeutics today announced that, consistent with the previously disclosed guidance from the EMA, the CHMP, a ...