Blog
RSS FeedPosted by Michael Wonder on 06 Jul 2020
Launch of public consultation on joint network strategy to 2025
6 July 2020 - EMA and the Heads of Medicines Agencies have developed a joint strategy for the next five ...
Posted by Michael Wonder on 01 Jul 2020
International regulators provide guiding principles for COVID-19 clinical trials
1 July 2020 - EMA has endorsed a joint statement on prioritisation of COVID-19 clinical trials published by the International ...
Posted by Michael Wonder on 30 Jun 2020
EMA and Korean Ministry of Food and Drug Safety to share confidential COVID-19 information
30 June 2020 - EMA and the Ministry of Food and Drug Safety of the Republic of Korea have signed ...
Posted by Michael Wonder on 25 Jun 2020
Emer Cooke nominated as new EMA Executive Director
25 June 2020 - The EMA Management Board has nominated Emer Cooke as the new Executive Director of the Agency. ...
Posted by Michael Wonder on 24 Jun 2020
Global regulators discuss data requirements for phase 3 trials of COVID-19 vaccines
24 June 2020 - Under the umbrella of the International Coalition of Medicines Regulatory Authorities, international regulators discussed COVID-19 vaccine ...
Posted by Michael Wonder on 23 Jun 2020
Academia developing medicines for rare diseases to receive free EMA scientific advice
23 June 2020 - To further encourage the development of treatments for rare diseases, EMA will waive all fees for ...
Posted by Michael Wonder on 22 Jun 2020
European Commission, EMA and FDA agree new priorities to strengthen their collaboration on medicines
22 June 2020 - Senior officials from the European Commission, EMA and the United States FDA held their 2020 bilateral ...
Posted by Michael Wonder on 18 Jun 2020
International regulators stress value of safe and effective vaccines
18 June 2020 - EMA has endorsed two statements about the importance, safety and effectiveness of vaccines published today by the ...
Posted by Michael Wonder on 16 Jun 2020
Advancing structured decision‐making in drug regulation at the FDA and EMA
11 June 2020 - FDA’s recent benefit‐risk framework was developed for improving the clarity and consistency in communicating the reasoning behind ...
Posted by Michael Wonder on 15 Jun 2020
Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19 – update #4
15 June 2020 - The International Coalition of Medicines Regulatory Authorities convened its regular virtual meeting of regulators from around ...
Posted by Michael Wonder on 14 Jun 2020
EMA management board backs rolling review fees, COVID-19 transparency measures
12 June 2020 - After its June meeting on Thursday, the EMA’s management board said it has approved a new ...
Posted by Michael Wonder on 08 Jun 2020
EU actions to support availability of medicines during COVID-19 pandemic – update #7
8 June 2020 - The EU Executive Steering Group on Shortages of Medicines Caused by Major Events held a virtual ...
Posted by Michael Wonder on 31 May 2020
COVID-19: reminder of the risks of chloroquine and hydroxychloroquine
29 May 2020 - The EMA is reminding health care professionals to closely monitor patients with COVID-19 who are receiving ...
Posted by Michael Wonder on 31 May 2020
Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19 – update #3
28 May 2020 - As part of its coordinated response to the pandemic, the International Coalition of Medicines Regulatory Authorities ...
Posted by Michael Wonder on 28 May 2020
European medicines regulatory network fully mobilised in fight against COVID-19
28 May 2020 - The development and availability of medicines and vaccines for all patients in the European Union, including those ...