International regulators discuss available knowledge supporting COVID-19 medicine development
On 2 April, regulators from around the world joined the second workshop on COVID-19 organised by the European Medicines Agency (EMA) under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA). Participants from more than 25 countries, representing 28 medicines regulatory authorities globally and experts from the World Health Organization and the European Commission discussed the available knowledge on possible treatments (drugs and biologics) for COVID-19, including:
- Progress on COVID-19 medicine development
- Availability of potential COVID-19 treatments
- Ongoing and planned clinical trials
- Compassionate use and off-label use of medicines in the context of COVID-19
The goal of the meeting was to exchange information about the progress made on the development of potential COVID-19 therapeutics and to reaffirm the need for large clinical trials, which are most likely to generate the conclusive evidence needed to enable faster development and approval of treatments for COVID-19.
The workshop was co-chaired by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and EMA. It was the second in a series of COVID-19 workshops held by ICMRA. The first workshop, focusing on the development of vaccines to prevent COVID-19, was held on 18 March and was co-chaired by the US Food and Drug Administration (FDA) and EMA.
The discussions were moderated by Marco Cavaleri, Head of Biological Health Threats and Vaccines Strategy at EMA, and Junko Sato, Office Director of the Office of International Program at PMDA. More details on the discussions and the outcomes of the meeting will be shared in the coming days.