Blog
RSS FeedPosted by Michael Wonder on 14 Sep 2021
EMA study reveals need for RWE framework, submission structure
14 September 2021 - The EMA has identified a need for more consistency in how real world evidence is submitted. ...
Posted by Michael Wonder on 16 Aug 2021
Artificial intelligence in medicine regulation
16 August 2021 - The International Coalition of Medicines Regulatory Authorities sets out recommendations to help regulators to address the ...
Posted by Michael Wonder on 06 Aug 2021
Interoperability of track and trace systems: key to public health protection
6 August 2021 - EMA has endorsed recommendations developed by the International Coalition of Medicines Regulatory Authorities to facilitate the use ...
Posted by Michael Wonder on 16 Jul 2021
International regulators work towards alignment on development and authorisation of second generation COVID-19 vaccines
16 July 2021 - Regulatory convergence is critical for expediting and streamlining global development and authorisation of new or modified COVID-19 ...
Posted by Michael Wonder on 13 Jul 2021
European efforts to assess Russia’s Sputnik V vaccine stymied by data gaps
13 July 2021 - The developers of Russia’s Sputnik V coronavirus vaccine have repeatedly failed to provide data that regulators ...
Posted by Michael Wonder on 19 Jun 2021
European regulator EMA says it won't set 50% efficacy threshold for COVID shots
18 June 2021 - The EMA said on Thursday it would not impose a 50% efficacy threshold for COVID-19 vaccines, ...
Posted by Michael Wonder on 14 Jun 2021
Vaxzevria: EMA advises against use in people with history of capillary leak syndrome
11 June 2021 - EMA’s safety committee (PRAC) has concluded that people who have previously had capillary leak syndrome must not ...
Posted by Michael Wonder on 03 Jun 2021
EU regulators develop recommendations to forecast demand of medicines
3 June 2021 - The EU Executive Steering Group on Shortages of Medicines Caused by Major Events has adopted a ...
Posted by Michael Wonder on 26 May 2021
Medical device regulation comes into application
26 May 2021 - The medical device regulation, which was adopted in April 2017, changes the European legal framework for medical ...
Posted by Michael Wonder on 23 May 2021
EU regulator backs extending approval for remdesivir for another year
21 May 2021 - The EMA on Friday recommended extending conditional marketing approval by a year for Gilead Sciences’ COVID-19 ...
Posted by Michael Wonder on 11 May 2021
Additional measures to allow experts to focus on COVID-19 activities
11 May 2021 - EMA is implementing additional temporary measures to further streamline activities in the European medicines regulatory network ...
Posted 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 ...