Blog
RSS FeedPosted by Michael Wonder on 11 Nov 2019
‘Regulatory science to 2025’: live broadcast of post-consultation workshop
11 November 2019 - The European Medicines Agency is hosting a multi-stakeholder workshop on the human medicine aspects of its ...
Posted by Michael Wonder on 26 Oct 2019
Dialogue with Chinese authorities on medicine regulation
25 October 2019 - The Deputy Commissioner of the Chinese National Medical Product Administration, Dr Chen Shifei, visited EMA on ...
Posted by Michael Wonder on 21 Oct 2019
Enhancing consistency in wording of therapeutic indications to support health care decision-making
21 October 2019 - EMA’s human medicines committee has developed a paper to strengthen consistency when defining therapeutic indications in the ...
Posted by Michael Wonder on 06 Oct 2019
Europe’s drug agency warns on work crunch after Brexit move
4 October 2019 - Europe’s drug regulator warned that it will struggle to finish planned work for the year after ...
Posted by Michael Wonder on 26 Sep 2019
Change of name of liposomal medicines at high risk of medication errors
26 September 2019 - Marketing authorisation holders of medicines containing liposomal drug delivery systems are requested to submit a variation ...
Posted by Michael Wonder on 25 Sep 2019
Paper by European regulators foresees "continuing reduction in clinical data requirements" for biosimilars
24 September 2019 - This month, Elena Wolff-Holz, chair of the EMA’s Biosimilar Medicinal Products Working Party, together with co-authors from ...
Posted by Michael Wonder on 19 Sep 2019
Flawed evidence underpins approval of new cancer drugs
18 September 2019 - We must raise the bar to ensure real benefits for patients ...
Posted by Michael Wonder on 19 Sep 2019
Design characteristics, risk of bias, and reporting of randomised controlled trials supporting approvals of cancer drugs by European Medicines Agency, 2014-16: cross sectional analysis
18 September 2019 - In this study, the investigators examined the characteristics of randomised controlled trials that supported approval of cancer ...
Posted by Michael Wonder on 11 Sep 2019
Biosimilar and interchangeable: inseparable scientific concepts?
4 September 2019 - As defined by the European Commission, the term interchangeability refers to “the possibility of exchanging one medicine ...
Posted by Michael Wonder on 11 Sep 2019
The use of validated and non-validated surrogate endpoints in two EMA expedited approval pathways: A cross-sectional study of products authorised 2011–2018
10 September 2019 - In situations of unmet medical need or in the interests of public health, expedited approval pathways, ...
Posted by Michael Wonder on 03 Sep 2019
Added therapeutic benefit and drug licensing
3 September 2019 - One aspect of the ongoing debate about drug pricing is the added therapeutic benefit of new drugs ...
Posted by Michael Wonder on 18 Aug 2019
EMA and FDA historically agree on just about every new drug approval, but is that slowly changing?
16 August 2019 - The EMA and US FDA concur more than 90% of the time in their decisions to ...
Posted by Michael Wonder on 16 Aug 2019
EMA/FDA analysis shows high degree of alignment in marketing application decisions between EU and US
16 August 2019 - EMA and the US FDA are aligned in more than 90% of marketing authorisation decisions for ...
Posted by Michael Wonder on 31 Jul 2019
Names of liposomal medicines to be changed to avoid medication errors
31 July 2019 - All marketing authorisation holders of medicines containing liposomal drug delivery systems are requested to submit to ...
Posted by Michael Wonder on 23 Jul 2019
European Medicines Agency is advised to take steps to avoid bias concerns over approvals
22 July 2019 - Following a two-year inquiry, the European Ombudsman has recommended the European Medicines Agency take several steps ...