Blog
RSS FeedPosted by Michael Wonder on 16 Dec 2020
Pressure mounts on EU drug regulator to approve Pfizer COVID-19 vaccine
15 December 2020 - Europe’s drug regulator is under increasing pressure to quickly approve the COVID-19 vaccine developed by U.S. giant ...
Posted by Michael Wonder on 08 Dec 2020
Joint strategy sets direction for EMA and EU medicines regulatory agencies to 2025
8 December 2020 - The EMA and the Heads of Medicines Agencies (HMA) have published their joint strategy for ...
Posted by Michael Wonder on 25 Nov 2020
EU drug regulator could rule on COVID-19 vaccines by year end
24 November 2020 - The EMA could produce a scientific opinion on COVID-19 vaccines seeking regulatory approval by the end ...
Posted by Michael Wonder on 23 Nov 2020
Workshop on regulatory support for development of orphan medicines
23 November 2020 - On Monday, 30 November, EMA is hosting a workshop to discuss the benefits and impact of ...
Posted by Michael Wonder on 20 Nov 2020
Update on remdesivir - EMA will evaluate new data from Solidarity trial
20 November 2020 - EMA is aware that the World Health Organization has updated its guidelines advising against the use ...
Posted by Michael Wonder on 20 Nov 2020
HMA/EMA statement on approval of vaccines
20 November 2020 - Development and deployment of safe and effective vaccines is seen as an essential element in the management ...
Posted by Michael Wonder on 19 Nov 2020
EMA organises public meeting on COVID-19 vaccines
19 November 2020 - EMA will organise a public meeting on 11 December 2020 to inform European citizens about the ...
Posted by Michael Wonder on 16 Nov 2020
Emer Cooke takes office as head of EMA
16 November 2020 - Emer Cooke has begun her mandate as Executive Director of the European Medicines Agency today. ...
Posted by Michael Wonder on 06 Nov 2020
International regulators and WHO join forces to address COVID-19 challenges
6 November 2020 - The International Coalition of Medicines Regulatory Authorities and the World Health Organization have committed to working together ...
Posted by Michael Wonder on 05 Nov 2020
EMA will assess potential COVID-19 vaccine on ‘case by case’ basis
5 November 2020 - Agency will not specify a minimum level of efficacy. ...
Posted by Michael Wonder on 31 Oct 2020
Extra transparency measures for COVID-19 vaccines and therapeutics
30 October 2020 - Today the EMA has implemented two further extra transparency measures for COVID-19 medicines, by publishing both ...
Posted by Michael Wonder on 26 Oct 2020
European Union would apply lower threshold in assessing COVID-19 vaccine
25 October 2020 - The EU’s drug regulator is willing to approve a vaccine even if it were effective in less ...
Posted by Michael Wonder on 23 Oct 2020
Strengthening global collaboration on COVID-19 real-world evidence and observational studies
23 October 2020 - Medicines regulators from around the world discussed their experiences with supporting and assessing real-world evidence to facilitate ...
Posted by Michael Wonder on 19 Oct 2020
EMA virtual conference: 25 years of advancing public and animal health
19 October 2020 - On 22 October 2020, EMA will mark 25 years of its strong commitment to protect public ...
Posted by Michael Wonder on 08 Oct 2020
Association between FDA and EMA expedited approval programs and therapeutic value of new medicines: retrospective cohort study
7 October 2020 - The investigators of the study set out to characterise the therapeutic value of new drugs approved ...