Blog
RSS FeedPosted by Michael Wonder on 20 Jul 2019
EMA takes note of the European Ombudsman’s decision on pre-submission activities
19 July 2019 - EMA welcomes the European Ombudsman’s recognition of the value and need for scientific advice and her ...
Posted by Michael Wonder on 19 Jul 2019
Patient registries may prove valuable in regulatory decisions, EMA study finds
18 July 2019 - Although patient registries can be heterogenous in their quality and design, a new study in Drug ...
Posted by Michael Wonder on 15 Jul 2019
Report on the current status of the use of real‐world data and real‐world evidence in drug development and regulation
10 July 2019 - Radically expanding use of real‐world data and real‐world evidence holds the potential to substantially impact drug development, ...
Posted by Michael Wonder on 08 Jul 2019
Guido Rasi elected chair of International Coalition of Medicines Regulatory Authorities
8 July 2019 - The International Coalition of Medicines Regulatory Authorities has elected EMA’s Executive Director Guido Rasi as its ...
Posted by Michael Wonder on 04 Jul 2019
EMA confirms WeWork as new sub-tenant for 30 Churchill Place; EMA also settles court case with Canary Wharf Group
4 July 2019 - The European Medicines Agency has reached an agreement with Canary Wharf Ltd over its premises at ...
Posted by Michael Wonder on 27 Jun 2019
One additional country to benefit from EU-US mutual recognition agreement for inspections
27 June 2019 - On 26 June 2019, Germany was included into the mutual recognition agreement between the European Union ...
Posted by Michael Wonder on 18 Jun 2019
EMA to reinstate some activities halted by Brexit
17 June 2019 - While noting some progress in its Brexit preparations on transferring medicine marketing authorizations from the UK ...
Posted by Michael Wonder on 11 Jun 2019
Two additional countries to benefit from EU-US mutual recognition agreement for inspections
11 June 2019 - On 10 June 2019, Luxembourg and the Netherlands were included into the mutual recognition agreement between ...
Posted by Michael Wonder on 06 Jun 2019
Strengthening engagement between EMA and general practitioners
6 June 2019 - EMA and the two major organisations representing general practitioners (GPs) and family physicians in Europe – ...
Posted by Michael Wonder on 04 Jun 2019
The European Medicines Agency’s goals for regulatory science to 2025
4 June 2019 - It is increasingly important that regulatory agencies catalyse the translation of scientific and technological innovation into improved ...
Posted by Michael Wonder on 16 May 2019
Will drugs companies follow EU agency from London to Amsterdam?
16 May 2019 - Amid the bustling skyscrapers of London’s Canary Wharf, one building stands silent and shuttered — a ...
Posted by Michael Wonder on 14 May 2019
EMA begins search for next Executive Director
14 May 2019 - As Guido Rasi wraps up his second five-year term as the executive director of the European ...
Posted by Michael Wonder on 07 May 2019
Working together for safe medicines in the EU
6 May 2019 - EMA launches a social media campaign to highlight how the European medicines regulatory network keeps medicines ...
Posted by Michael Wonder on 25 Apr 2019
European Medicines Agency to appeal Brexit lease case
25 April 2019 - The European Medicines Agency, one of the EU's biggest regulators, is appealing against a London ruling ...
Posted by Michael Wonder on 11 Apr 2019
The role of regulators in establishing added benefit of novel therapies
11 April 2019 - Regulators have a role to play in ensuring that there is a solid evidence base to support ...