Blog
RSS FeedPosted 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 ...
Posted 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 ...