Blog
RSS FeedPosted by Michael Wonder on 23 Jan 2019
EMA relocation updates
23 January 2019 - The EMA will physically relocate to the Netherlands in early March 2019. ...
Posted by Michael Wonder on 23 Jan 2019
No new patients should start treatment with Lartruvo after study shows cancer medicine does not prolong life
23 January 2019 - Preliminary results from the ANNOUNCE study show that Lartruvo (olaratumab) in combination with doxorubicin is not ...
Posted by Michael Wonder on 21 Jan 2019
Europe closer to biosimilar rule change, despite fierce resistance from pharma
18 January 2019 - EFPIA says it weakens IP commitment - supporters say it will boost exports. ...
Posted by Michael Wonder on 16 Jan 2019
EMA to lose 25% of staff as hard Brexit approaches
14 January 2019 - As UK Prime Minister Theresa May’s Brexit deal is expected to be rejected Tuesday in a ...
Posted by Michael Wonder on 12 Jan 2019
Time running out for ‘no-deal’ Brexit medicines laws
11 January 2019 - Needs parliament clearance before 29 March. ...
Posted by Michael Wonder on 04 Jan 2019
EMA highlights of 2018
4 January 2019 - EMA has published an overview of its recommendations of 2018 on the authorisation and safety ...
Posted by Michael Wonder on 30 Nov 2018
Revised guideline to assess risk of human medicines for the environment
30 November 2018 - EMA has published a PDF revision of its guideline on the environmental risk assessment ...
Posted by Michael Wonder on 29 Nov 2018
The evolution of adaptiveness: balancing speed and evidence
29 November 2018 - 'Adaptive' approaches to bringing drugs to market have been widely discussed in recent years. ...
Posted by Michael Wonder on 29 Nov 2018
Five additional countries to benefit from EU-US mutual recognition agreement for inspections
29 November 2018 - In November 2018, the US FDA confirmed the capability of five additional EU Member States to carry ...
Posted by Michael Wonder on 22 Nov 2018
Towards electronic product information for EU medicines
21 November 2018 - EMA, the Heads of Medicines Agencies and the European Commission are organising a workshop on 28 ...
Posted by Michael Wonder on 21 Nov 2018
Workshop on how to better support medicine developers in the generation and preparation of quality data packages for PRIME and Breakthrough Therapy application
20 November 2018 - EMA and the US FDA are organising a workshop on 26 November 2018 to discuss how ...
Posted by Michael Wonder on 15 Nov 2018
EMA seeks feedback on using registries for regulatory purposes
15 November 2018 - The EMA is seeking feedback on the use of patient disease registries for regulatory purposes. ...
Posted by Michael Wonder on 13 Nov 2018
EMA’s Brexit plans ensure Agency’s focus on medicines evaluation and supervision
13 November 2018 - A report on EMA’s 24 September 2018 meeting with industry stakeholders to discuss the UK’s withdrawal ...
Posted by Michael Wonder on 26 Oct 2018
Does fast-track drugs approval in EU run too fast?
25 October 2018 - In 2017, only 7 out of 92 medicines received a recommendation for marketing authorisation following an EU ...
Posted by Michael Wonder on 17 Oct 2018
Shaping regulatory science to 2025
17 October 2018 - EMA is hosting a workshop on Wednesday, 24 October to gather insight from stakeholders on the ...