Blog
RSS FeedPosted by Michael Wonder on 21 May 2020
EMA extends virtual-only meeting policy through August
20 May 2020 - The EMA has announced it is extending its decision to hold all upcoming meetings virtually through ...
Posted by Michael Wonder on 20 May 2020
Global regulators commit to cooperate on observational research in the context of COVID-19
20 May 2020 - Regulators from around the world have agreed three priority areas for cooperation on observational research during ...
Posted by Michael Wonder on 18 May 2020
EMA may conditionally authorise remdesivir in the ‘coming days’
18 May 2020 - The EMA's Executive Director Guido Rasi on Monday told a European Parliament committee that the agency ...
Posted by Michael Wonder on 18 May 2020
Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19 – update #2
18 May 2020 - The International Coalition of Medicines Regulatory Authorities (ICMRA) convened a virtual meeting of regulators from around ...
Posted by Michael Wonder on 18 May 2020
EU actions to support availability of medicines during COVID-19 pandemic – update #6
15 May 2020 - The EU Executive Steering Group on Shortages of Medicines Caused by Major Events held a virtual ...
Posted by Michael Wonder on 11 May 2020
EMA recommends expanding remdesivir compassionate use to patients not on mechanical ventilation
11 May 2020 - EMA’s human medicines committee (CHMP) has recommended expanding the compassionate use of the investigational medicine remdesivir ...
Posted by Michael Wonder on 08 May 2020
EU actions to support availability of medicines during COVID-19 pandemic – update #5
8 May 2020 - The EU Executive Steering Group on Shortages of Medicines Caused by Major Events held a virtual ...
Posted by Michael Wonder on 05 May 2020
Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19
5 May 2020 - In a high-level meeting on COVID-19 policies, organised by EMA under the umbrella of the International ...
Posted by Michael Wonder on 04 May 2020
EU approves label update for AstraZeneca's Lokelma
4 May 2020 - European regulators have approved a label update for AstraZeneca’s Lokelma (sodium zirconium cyclosilicate) to include a ...
Posted by Michael Wonder on 28 Apr 2020
International regulators pledge collective support to combat COVID-19 pandemic
28 April 2020 - EMA has endorsed a joint COVID-19 statement published today by the International Coalition of Medicines Regulatory ...
Posted by Michael Wonder on 25 Apr 2020
EU actions to support availability of medicines during COVID-19 pandemic – update #3
24 April 2020 - The EU Executive Steering Group on Shortages of Medicines Caused by Major Events held a virtual ...
Posted by Michael Wonder on 23 Apr 2020
Essential work to combat the COVID-19 pandemic to continue during EMA's closure on 27 April and on 1 May 2020
23 April 2020 - EMA has put measures in place to ensure that its activities related to the COVID-19 pandemic ...
Posted by Michael Wonder on 23 Apr 2020
COVID-19: reminder of risk of serious side effects with chloroquine and hydroxychloroquine
23 April 2020 - Chloroquine and hydroxychloroquine are known to potentially cause heart rhythm problems, and these could be exacerbated ...
Posted by Michael Wonder on 21 Apr 2020
Launch of enhanced monitoring system for availability of medicines used for treating COVID-19
21 April 2020 - EMA, together with the pharmaceutical industry and the EU Member States, has launched its enhanced fast-track ...
Posted by Michael Wonder on 20 Apr 2020
Update to guidance on regulatory expectations in the context of COVID-19 pandemic
20 April 2020 - The European Commission, EMA and the national competent authorities have agreed a series of measures to ...