2 October 2018 - The EMA and the European Commission’s Directorate-General for Health and Food Safety (DG SANTE) have published ...
19 June 2018 - The EMA has launched a new secure online portal for orphan designationExternal link icon applications. ...
19 June 2018 - The EMA published in July 2017 a guideline for first‐in‐human drug studies. ...
13 June 2018 - The pathway for bringing a new medicine to the market is dependent on two sequential processes: achieving ...
24 May 2018 - Workshop with regulators from EU, Japan and US open for registration ...
22 May 2018 - Live broadcast of workshop with European Reference Networks on 29 May. ...
7 May 2018 - Driving innovation to where it is most needed. ...
30 April 2018 - Update to recommendations issued in March 2018. ...
26 April 2018 - EMA launches public consultation on revised guideline on clinical evaluation of vaccines. ...
26 March 2018 - EU advice based on WHO recommendations. ...
19 March 2018 - Event to be broadcast live on 20 March. ...
28 February 2018 - European regulators are following in the footsteps of the U.S. Food and Drug Administration with plans ...
2 February 2018 - Guideline to streamline procedures and better address the specific requirements of ATMP developers published for consultation ...
31 January 2018 - EMA and European Commission invite stakeholders to register for joint workshop and support development of an ...
30 January 2018 - The “Parallel regulatory-HTA scientific advice” procedure allows manufacturers to receive simultaneous feedback from both EU regulators and ...