Blog
RSS FeedPosted by Michael Wonder on 01 Apr 2019
Regulatory information – 1.7% increase of fees from 1 April 2019
1 April 2019 - General, non-pharmacovigilance fees payable to EMA by applicants and marketing-authorisation holders are increasing by 1.7% on ...
Posted by Michael Wonder on 28 Mar 2019
20 years of sampling and testing programme for medicines authorised for the EU
28 March 2019 - EMA and the European Directorate for the Quality of Medicines & Healthcare have reviewed EMA’s sampling ...
Posted by Michael Wonder on 27 Mar 2019
New EudraVigilance system improves reporting of side effects and detection of safety signals
27 March 2019 - The new and improved EudraVigilance, the European system for managing and analysing information on suspected adverse ...
Posted by Michael Wonder on 11 Mar 2019
EMA now operating from Amsterdam
11 March 2019 - As of today, EMA is operating from Amsterdam. ...
Posted by Michael Wonder on 04 Mar 2019
Regulatory information – adjusted fees for applications to EMA from 1 April 2019
1 March 2019 - The EMA reminds applicants and marketing authorisation holders that adjusted fees for all applications, except for ...
Posted by Michael Wonder on 28 Feb 2019
First guidance on new rules for certain medical devices
28 February 2019 - EMA has published today the first of a series of guidance documents to help applicants prepare ...
Posted by Michael Wonder on 20 Feb 2019
Brexit doesn't mean EU agency can break Canary Wharf lease
20 February 2019 - EU departure doesn’t allow medicines agency to break its lease. ...
Posted by Michael Wonder on 19 Feb 2019
Big opportunities in big data, but EMA and industry just getting started
18 February 2019 - 250m genomes sequenced, but data trapped in silos. ...
Posted by Michael Wonder on 15 Feb 2019
Role of big data for evaluation and supervision of medicines in the EU
15 February 2019 - Recommendations for a path towards understanding the acceptability of evidence derived from ‘Big data’ in support ...
Posted by Michael Wonder on 11 Feb 2019
Fake drugs could put patients at risk after no-deal Brexit
8 February 2019 - Patients could be put at risk from fake medicines if the UK exits the EU without ...
Posted by Michael Wonder on 08 Feb 2019
EMA launches checklist to facilitate validation for initial marketing authorisation applications
8 February 2019 - A survey launched by EMA in September 2016 shows that validation issues occur in 90% of ...
Posted by Michael Wonder on 31 Jan 2019
Public consultation on key principles for the electronic product information of EU medicines
31 January 2019 - EMA, the Heads of Medicines Agencies and the European Commission are launching today a six-month public ...
Posted by Michael Wonder on 31 Jan 2019
A review of patient reported outcomes labelling for oncology drugs approved by the FDA and the EMA (2012-2016)
31 January 2019 - In recent years, the FDA has granted patient-reported outcome labelling to very few oncology drugs. ...
Posted by Michael Wonder on 30 Jan 2019
Farewell London, hallo Amsterdam: EMA lowers flag on 24 years in UK
29 January 2019 - Last Friday staff from the European Medicines Agency lowered the 28 flags of EU member states ...
Posted by Michael Wonder on 27 Jan 2019
Key EU medicines regulator closes London office with loss of 900 jobs
26 January 2019 - European Medicines Agency heads for Amsterdam 63 days before Brexit. ...