Blog
RSS FeedPosted by Michael Wonder on 01 Apr 2020
COVID-19: chloroquine and hydroxychloroquine only to be used in clinical trials or emergency use programmes
1 April 2020 - Chloroquine and hydroxychloroquine, two medicines currently authorised for malaria and certain autoimmune diseases, are being investigated ...
Posted by Michael Wonder on 01 Apr 2020
Regulatory information - 1.6% increase in fees from 1 April 2020
1 April 2020 - General, non-pharmacovigilance fees payable to EMA by applicants and marketing-authorisation holders are increasing by 1.6% on ...
Posted by Michael Wonder on 31 Mar 2020
Expanded access as a source of real‐world data: an overview of FDA and EMA approvals
22 March 2020 - The authors set out to identify, characterise, and compare all FDA and EMA approvals that included real‐world ...
Posted by Michael Wonder on 30 Mar 2020
EMA to issue electronic certificates for medicines
30 March 2020 - EMA has implemented a new system to issue electronic certificates for human and veterinary medicines. ...
Posted by Michael Wonder on 11 Mar 2020
COVID-19: EMA meetings with delegates and experts will be held virtually until end April 2020
11 March 2020 - As a precautionary measure, all meetings of EMA committees and working parties will be held virtually ...
Posted by Michael Wonder on 02 Mar 2020
EMA organisational changes come into effect
2 March 2020 - As of today, EMA has implemented changes to its organisational structure. ...
Posted 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 ...