Blog
RSS FeedPosted by Michael Wonder on 07 Apr 2021
AstraZeneca’s COVID-19 vaccine: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets
7 April 2021 - EMA confirms overall benefit-risk remains positive. ...
Posted by Michael Wonder on 16 Mar 2021
EU regulators team up with U.S. and UK on pharmaceutical mergers
16 March 2021 - EU antitrust enforcers have teamed up with their U.S. and British counterparts to share expertise on ...
Posted by Michael Wonder on 10 Mar 2021
Developers of Russian Sputnik V vaccine doubt EU regulator's neutrality, want apology
9 March 2021 - The developers of Russia’s Sputnik V vaccine against COVID-19 on Tuesday questioned the EMA's neutrality, after ...
Posted by Michael Wonder on 02 Mar 2021
EMA and Health Canada publish clinical data used to support their authorisations of the Moderna COVID-19 vaccine
2 March 2021 - Openness and transparency are key to building confidence in COVID-19 vaccines. Today, EMA and Health Canada ...
Posted by Michael Wonder on 25 Feb 2021
International cooperation to align approaches for regulation of COVID-19 vaccines and medicines
25 February 2021 - Regulators around the globe are committed to aligning their regulatory requirements and addressing knowledge gaps to facilitate ...
Posted by Michael Wonder on 22 Feb 2021
EMA publishes agenda for 22-25 February CHMP meeting
22 February 2021 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 22 Feb 2021
EMA plots earlier engagement with patient groups
19 February 2021 - The EMA on Friday announced it will pilot an early engagement program to bring patient and ...
Posted by Michael Wonder on 10 Feb 2021
Drug maker will slash prices on cancer medicines to end price gouging probe in Europe
10 February 2021 - After months of deliberation, the European Commission has accepted an offer from Aspen Pharma to reduce ...
Posted by Michael Wonder on 08 Feb 2021
International regulators working together to enhance collaboration on COVID-19 observational research
8 February 2021 - In a dedicated COVID-19 workshop, convened under the umbrella of the International Coalition of Medicines Regulatory Authorities, ...
Posted by Michael Wonder on 04 Feb 2021
EMA COVID-19 assessments ‘OPEN’ to non-EU regulators
4 February 2021 - EMA is piloting a new ‘OPEN’ initiative to increase international collaboration on the evaluation of COVID-19 vaccines ...
Posted by Michael Wonder on 21 Jan 2021
Human medicines: highlights of 2020
21 January 2021 - EMA has published an PDF iconoverview of its key recommendations in 2020 on the authorisation and ...
Posted by Michael Wonder on 19 Jan 2021
Global regulators highlight key role of health care professionals in fostering confidence in COVID-19 vaccines
19 January 2021 - EMA has endorsed a joint statement published today by the International Coalition of Medicines Regulatory Authorities ...
Posted by Michael Wonder on 19 Jan 2021
The European Medicines Agency's EU conditional marketing authorisations for COVID-19 vaccines
13 January 2021 - Few medicines are awaited as eagerly as COVID-19 vaccines. ...
Posted by Michael Wonder on 30 Dec 2020
Update on rolling review of AstraZeneca’s COVID-19 vaccine
30 December 2020 - EMA’s assessment of the COVID-19 vaccine being developed by AstraZeneca and Oxford University has been progressing ...
Posted by Michael Wonder on 22 Dec 2020
EMA organises a second public meeting about the new COVID-19 vaccines
22 December 2020 - EMA will organise a second public meeting on 8 January 2021 to inform European citizens about ...