Blog
RSS FeedPosted by Michael Wonder on 04 Feb 2020
EU flags are up in EMA’s new building in Amsterdam
3 February 2020 - EMA’s staff gathered today to raise the EU flags in the lobby of its new and ...
Posted by Michael Wonder on 01 Feb 2020
Highlights from the CHMP 27-30 January 2020 meeting
31 January 2020 - Fifteen new medicines recommended for approval. ...
Posted by Michael Wonder on 31 Jan 2020
UK withdrawal from the EU on 31 January 2020
31 January 2020 - The United Kingdom will formally leave the European Union on 31 January 2020 and will become ...
Posted by Michael Wonder on 29 Jan 2020
Documents disclosed to the EMA as part of an MA application process are not presumed to be confidential
28 January 2020 - On 22 January 2020 the CJEU handed down two decisions in which it decided that the ...
Posted by Michael Wonder on 29 Jan 2020
Key principles for the use of electronic product information for EU medicines
29 January 2020 - EMA, the Heads of Medicines Agencies of EU Member States and the European Commission (EC) have ...
Posted by Michael Wonder on 28 Jan 2020
EMA celebrates 25 years advancing public and animal health
27 January 2020 - This week marks EMA’s 25th anniversary. ...
Posted by Michael Wonder on 22 Jan 2020
Court of Justice upholds EMA’s approach to transparency
22 January 2020 - EMA welcomes today’s two appellate judgments by the Court of Justice that confirmed, in clear and ...
Posted by Michael Wonder on 20 Jan 2020
Ten recommendations to unlock the potential of big data for public health in the EU
20 January 2020 - The joint Big Data Task Force of EMA and the Heads of Medicines Agencies proposes ten ...
Posted by Michael Wonder on 09 Jan 2020
Human medicines: highlights of 2019
9 January 2020 - EMA has published a review of its key recommendations in 2019 on the authorisation and safety ...
Posted by Michael Wonder on 11 Dec 2019
Six-year review shows success of the EU signal management system in improving safe use of medicines
11 December 2019 - In the first six years since the implementation of the 2012 EU pharmacovigilance legislation, the EU ...
Posted by Michael Wonder on 02 Dec 2019
Engaging patients in medicines regulation: a tale of two agencies
2 December 2019 - The EMA and the US FDA have committed to engaging patients in their regulatory processes to promote ...
Posted by Michael Wonder on 30 Nov 2019
Big data
27 November 2019 - Massive amounts of data are generated on a daily basis that could potentially be harnessed to ...
Posted by Michael Wonder on 26 Nov 2019
EMA adopts EU Ombudsman recommendations to avoid bias concerns over drug approvals
26 November 2019 - Seeking to end another flap about transparency, the European Medicines Agency has agreed to recommendations made ...
Posted by Michael Wonder on 15 Nov 2019
Dutch authorities hand over final building to EMA in Amsterdam
15 November 2019 - Today, the Dutch authorities have handed over to EMA its newly built tailor-made premises, located in ...
Posted by Michael Wonder on 13 Nov 2019
Regulators’ advice can make a difference for faster patient access to highly innovative therapies
12 November 2019 - Early dialogue and frequent interactions between medicine developers, regulators, health technology assessment bodies and patients can play ...