Blog
RSS FeedPosted by Michael Wonder on 15 Dec 2018
Highlights from the CHMP 10-13 December 2018 meeting
14 December 2018 - EMA’s CHMP recommended seven medicines for approval at its December 2018 meeting. ...
Posted by Michael Wonder on 15 Sep 2018
Compliance with requirement to report results on the EU Clinical Trials Register: cohort study and web resource
12 September 2018 - Following the 2012 EC guideline, sponsors must ensure that all trials registered on EUCTR since 2004 disclose ...
Posted by Michael Wonder on 16 Jul 2018
EMA’s proactive publication of clinical data a success
16 July 2018 - First report on unprecedented transparency policy shows high user satisfaction. ...
Posted by Michael Wonder on 19 Jun 2018
Modernising the orphan designation process
19 June 2018 - The EMA has launched a new secure online portal for orphan designationExternal link icon applications. ...
Posted by Michael Wonder on 29 May 2018
EMA publishes agenda for 28-31 May CHMP meeting
28 May 2018 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 02 May 2018
EMA 2017 annual report published
2 May 2018 - Report highlights major achievements and includes key figures ...
Posted by Michael Wonder on 24 Apr 2018
EMA publishes agenda for 23-26 April CHMP meeting
23 April 2018 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 17 Apr 2018
Final minutes of December 2017 EMA/EUnetHTA meeting
16 April 2018 - The EMA has published the final minutes from the 15 December 2017 meeting. ...
Posted by Michael Wonder on 23 Jan 2018
Human medicines: highlights of 2017
23 January 2018 - 92 medicines recommended for approval, including 35 with a new active substance. ...
Posted by Michael Wonder on 15 Nov 2017
EMA to work with stakeholders to improve the product information for EU medicines
15 November 2017 - Stakeholder feedback sought on ongoing electronic initiatives ...
Posted by Michael Wonder on 10 Aug 2017
Science and innovation for better medicines
10 August 2017 - EMA leaflet shows how work of the Agency benefits patients. ...
Posted by Michael Wonder on 29 Jul 2017
Concept paper on development and lifecycle of personalised medicines and companion diagnostic
28 July 2017 - Public consultation to end on 31 October 2017. ...
Posted by Michael Wonder on 26 Apr 2017
EMA publishes withdrawal assessment report for Graspa
25 April 2017 - On 14 November 2016, Erytech Pharma officially notified the CHMP that it wishes to withdraw its application ...
Posted by Michael Wonder on 23 Mar 2017
Call for experts in anonymisation of clinical data
23 March 2017 - EMA to set up technical group in the context of the publication of clinical data ...
Posted by Michael Wonder on 16 Mar 2017
EMA publishes updated list of applications for new human medicines under evaluation by the CHMP
16 March 2017 - This document lists information on applications for centralised marketing authorisation for human medicines that the EMA ...