Blog
RSS FeedPosted by Michael Wonder on 23 Jul 2019
EMA publishes agenda for 22-25 July CHMP meeting
22 July 2019 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 03 Jul 2019
Call for all sponsors to publish clinical trial results in EU database
3 July 2019 - The European Commission, the European Medicines Agency and the Heads of Medicines Agencies have co-signed a ...
Posted by Michael Wonder on 04 Jun 2019
Consultation on draft guideline on quality requirements for medical devices in combination products
3 June 2019 - EMA has released a draft guideline on the quality requirements for medical devices in human medicines ...
Posted by Michael Wonder on 27 May 2019
EMA publishes agenda for 27-29 2019 May CHMP meeting
27 May 2019 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 29 Mar 2019
Highlights from CHMP 25-28 March 2019 meeting
29 March 2019 - EMA’s human medicines committee (CHMP) adopted recommendations for one new initial marketing authorisation and three extensions ...
Posted by Michael Wonder on 25 Mar 2019
EMA publishes agenda for 25-28 March CHMP meeting
25 March 2019 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 27 Feb 2019
EMA publishes agenda for 25-28 February 2019 CHMP meeting
25 February 2019 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 14 Jan 2019
Revised guideline aims to strengthen global approach to development of new antibacterial medicines
14 January 2019 - EMA has published a PDF revision of its guideline on the evaluation of human medicines ...
Posted 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. ...