International regulators emphasize the need for reliable evidence on COVID-19 treatment
Today, the international regulators have published a report highlighting their reflections on the development of potential COVID-19 therapies, clinical trials, and compassionate use programs. The report presents the results of a virtual meeting from April 2nd, 2020 on COVID-19 therapeutic medicine development, which was organized by the European Medicines Agency (EMA) under the patronage of the International Coalition of Medicines Regulatory Authorities (ICMRA).
Key topics:
- Progress on COVID-19 medicine development
- Ongoing and planned clinical trials
- Compassionate use and off-label use of medicines in the context of COVID-19
- Availability of potential COVID-19 treatments
To date, no drug has shown clear efficacy in the treatment of COVID-19. Workshop participants expressed the need to gather reliable evidence to determine the safety and efficacy of proposed drugs in the COVID-19 treatment. It has been agreed that multi-center randomized controlled trials (RCTs) are the best way to generate the data needed to quickly develop and validate potential COVID-19 treatments. Participants acknowledged that small studies or compassionate use programs are unlikely to be able to provide the required level of evidence to allow clear-cut recommendations.
Participants agreed to exchange information about the ongoing trials and results to support global approach. In the coming months, ICMRA will organize another regulatory workshop to discuss developments in COVID-19 treatment.
About the meeting:
The meeting brought together delegates from over 25 countries, representing 28 drug regulatory authorities around the world, as well as experts from the World Health Organization and the European Commission to discuss available knowledge on possible treatments (drugs and biological substances) for COVID-19. The meeting was co-chaired by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) and EMA.
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This article provides general information and does not constitute regulatory or legal advice. Requirements should be confirmed for the specific study, applicable regulatory framework, and markets concerned.
