The European Commission launches an advisory panel on the novel coronavirus (COVID-19), and the European Medicines Agency and the FDA co-chair first global regulatory workshop on COVID-19.

European Commission Launches COVID-19 Advisory Panel; EMA Participates

The European Commission launched this week (March 17, 2020) an advisory panel on the novel coronavirus (COVID-19) composed of epidemiologists and virologists from different European Union (EU) member states to formulate EU guidelines on science-based and coordinated risk-management measures. This panel, which was created following a mandate by EU member states, is chaired by the EU Commission President, Ursula von der Leyen, and co-chaired by Stella Kyriakides, EU Commissioner for Health and Food Safety.

The panel will provide advice to the EU Commission on the following:

• Formulation of response measures to be addressed to all Member States in line with the different stages of the epidemic in the EU as a whole and taking into account particular EU member state contexts;

• Identification and mitigation of significant gaps, inconsistencies or inadequacies in measures taken or to be taken to contain and manage the spread of COVID-19, including in clinical management and treatment, and overcome its impact;

• Prioritization of healthcare, civil protection and other resources as well as support measures to be organized or coordinated at the EU level;

• Subsequently, recommendation of policy measures for addressing and mitigating long-term consequences of COVID-19.

The panel is composed of seven members from six EU member states who will act in their personal capacities and independently. The European Center for Disease Prevention and Control, the European Medicines Agency, and the Emergency Response Coordination Center will participate as observers. The members will deliberate at least twice a week – if not more – through videoconferencing, based on questions put forward by the EU Commission or on their own initiative.

Source:  European Commission

EMA, FDA Co-Chair First Global Regulatory Workshop on COVID-19

The first global regulatory workshop on the novel coronavirus (COVID-19), co-chaired by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), was convened this week (March 18, 2020) under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA). The goal of the meeting was to encourage exchange of information about the global efforts toward developing new vaccines against COVID-19.

The virtual meeting brought together delegates from 17 different countries, representing more than 20 medicines regulatory authorities globally as well as experts from the World Health Organization and the European Commission, to discuss the development of vaccines against COVID-19.

The workshop was moderated by Dr. Marco Cavaleri, Head of Biological Health Threats and Vaccines Strategy at the EMA, and Dr. Marion Gruber, Director of Office of Vaccines Research & Review at the FDA. The EMA said that further details on the discussions and outcomes from the meeting will be shared in the coming days. 

Source: European Medicines Agency

EMA Calls for Pooling EU Resources for Large Clinical Trials for COVID-19 Treatments and Vaccines

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a statement urging the European Union (EU) research community to work collaboratively to pool EU research resources to prioritize large, randomized controlled clinical studies for treatments against the novel coronavirus (COVID-19) through multi-center, multi-arm clinical trials.

The CHMP is calling for a harmonized approach to data collection and a robust methodology for COVID-19 clinical trials across the EU to make best use of the available supply of investigational agents and is also emphasizing the need to include all EU countries in these trials. CHMP says that the larger trials are most likely to generate the conclusive evidence needed to enable rapid development and approval of potential treatments of COVID-19.

Currently, there are no approved medicines to protect from or treat COVID-19. The CHMP has discussed the ongoing outbreak and is emphasizing the critical need for robust data to determine which investigational or repurposed medicinal products would be safe and effective for the treatment of COVID-19. The committee is concerned that clinical trials with a small number of participants or compassionate-use programs might not generate the data required to draw firm conclusions on the effects of a given therapeutic and give appropriate advice to healthcare professionals and patients.

The EMA is currently engaging with different stakeholders that can further support the conduct of COVID-19 clinical trials across Europe. The EMA is encouraging developers of potential therapeutics or vaccines against COVID-19 to contact the agency as soon as possible with information about their proposed development. The agency is also supporting EU member states by reporting to the agency any useful emerging information on investigational agents to treat or prevent COVID-19. The EMA has mobilized a team within the agency to work on this and the regulatory tools available to accelerate approval.

Source: European Medicines Agency