Blog
RSS FeedPosted by Michael Wonder on 11 May 2021
US, EU regulators discuss tailoring biosimilar approvals
11 May 2021 - A tailored approach to biosimilar approvals is conceived as the next big leap for regulatory advancement in ...
Posted by Michael Wonder on 26 Apr 2021
EMA and ECDC join forces for enhanced post-marketing monitoring of COVID-19 vaccines in Europe
26 April 2021 - The EMA and the European Centre for Disease Prevention and Control today kicked off a new ...
Posted by Michael Wonder on 21 Apr 2021
Clinical Trials Information System reaches major milestone towards go-live and application of the Clinical Trial Regulation
21 April 2021 - EMA’s Management Board confirmed that the clinical trial EU Portal and Database, one of the main deliverables ...
Posted by Michael Wonder on 15 Apr 2021
EU drug regulator to issue view on J&J vaccine next week
15 April 2021 - Europe's drug regulator said on Wednesday it planned to issue a recommendation on Johnson & Johnson's ...
Posted 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 ...