Blog
RSS FeedPosted by Michael Wonder on 14 Apr 2020
Regulators split on anti-malarials for COVID-19
11 April 2020 - US and French authorities have authorised the use of chloroquine and hydroxychloroquine, but the EU regulator and ...
Posted by Michael Wonder on 09 Apr 2020
EMA establishes task force to take quick and coordinated regulatory action related to COVID-19 medicines
9 April 2020 - As part of its health threat plan activated to fight COVID-19, the EMA has finalised and ...
Posted by Michael Wonder on 09 Apr 2020
Global regulators stress need for robust evidence on COVID-19 treatments
9 April 2020 - International regulators have published a report today highlighting their considerations on the development of potential COVID-19 ...
Posted by Michael Wonder on 07 Apr 2020
Global regulators discuss observational studies of real world data for COVID-19 medicines
7 April 2020 - In a dedicated COVID-19 workshop, organised by the EMA under the umbrella of the International Coalition of ...
Posted by Michael Wonder on 07 Apr 2020
Essential work to combat the COVID-19 pandemic to continue during EMA's Easter break from 9 to 13 April 2020
7 April 2020 - It is EMA's top priority to help save lives during the pandemic by expediting the development ...
Posted by Michael Wonder on 06 Apr 2020
EU authorities agree new measures to support availability of medicines used in the COVID-19 pandemic
6 April 2020 - The continued availability of medicines, in particular those used for patients with COVID-19, is of critical ...
Posted by Michael Wonder on 03 Apr 2020
EMA provides recommendations on compassionate use of remdesivir for COVID-19
3 April 2020 - During an extraordinary virtual meeting held on 2 April 2020, EMA’s CHMP gave recommendations on how ...
Posted by Michael Wonder on 03 Apr 2020
International regulators discuss available knowledge supporting COVID-19 medicine development
3 April 2020 - On 2 April, regulators from around the world joined the second workshop on COVID-19 organised by ...
Posted by Michael Wonder on 02 Apr 2020
EMA urges caution on malaria drugs' use for COVID-19 in absence of evidence
1 April 2020 - The European Union's drug regulator warned on Wednesday that two older malaria drugs being tested against ...
Posted by Michael Wonder on 01 Apr 2020
COVID-19: chloroquine and hydroxychloroquine only to be used in clinical trials or emergency use programmes
1 April 2020 - Chloroquine and hydroxychloroquine, two medicines currently authorised for malaria and certain autoimmune diseases, are being investigated ...
Posted by Michael Wonder on 01 Apr 2020
Regulatory information - 1.6% increase in fees from 1 April 2020
1 April 2020 - General, non-pharmacovigilance fees payable to EMA by applicants and marketing-authorisation holders are increasing by 1.6% on ...
Posted by Michael Wonder on 31 Mar 2020
Expanded access as a source of real‐world data: an overview of FDA and EMA approvals
22 March 2020 - The authors set out to identify, characterise, and compare all FDA and EMA approvals that included real‐world ...
Posted by Michael Wonder on 30 Mar 2020
EMA to issue electronic certificates for medicines
30 March 2020 - EMA has implemented a new system to issue electronic certificates for human and veterinary medicines. ...
Posted by Michael Wonder on 11 Mar 2020
COVID-19: EMA meetings with delegates and experts will be held virtually until end April 2020
11 March 2020 - As a precautionary measure, all meetings of EMA committees and working parties will be held virtually ...
Posted by Michael Wonder on 02 Mar 2020
EMA organisational changes come into effect
2 March 2020 - As of today, EMA has implemented changes to its organisational structure. ...